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Clinical Trial Results:
Vit-D in CRC - A Randomised Double Blind Placebo-Controlled Clinical Trial Of a Single Oral Cholecalciferol Treatment Against Surrogate End Point Biomarkers (SEBs) In Colon Cancer (CRC) Patients

Summary
EudraCT number	2013-001664-34
Trial protocol	GB
Global end of trial date	24 Apr 2018
Results information
Results version number	v1(current)
This version publication date	15 Aug 2019
First version publication date	15 Aug 2019
Other versions

Trial information Top of page
Trial identification
Sponsor protocol code	12028-FC-SS
Additional study identifiers
ISRCTN number	-
US NCT number	-
WHO universal trial number (UTN)	-
Sponsors
Sponsor organisation name	Belfast Health and Social Care Trust
Sponsor organisation address	Grosvenor Road, Belfast, United Kingdom, BT12 6BA
Public contact	Alison Murphy, Belfast Health and Social Care Trust, 44 02890636366, ResearchSponsor@belfasttrust.hscni.net
Scientific contact	Professor Frederick Charles Campbell, Queens University Belfast, 44 02890638468, f.c.campbell@qub.ac.uk
Sponsor organisation name	Queens University Belfast
Sponsor organisation address	University Road, Belfast, United Kingdom, BT7 1NN
Public contact	Louise Dunlop, Queens University Belfast, 44 02890972572, l.dunlop@qub.ac.uk
Scientific contact	Professor Frederick Charles Campbell, Queens University Belfast, 44 02890638468, f.c.campbell@qub.ac.uk
Paediatric regulatory details
Is trial part of an agreed paediatric investigation plan (PIP)	No
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?	No
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?	No
Results analysis stage
Analysis stage	Final
Date of interim/final analysis	29 Apr 2019
Is this the analysis of the primary completion data?	Yes
Primary completion date	19 Apr 2017
Global end of trial reached?	Yes
Global end of trial date	24 Apr 2018
Was the trial ended prematurely?	No
General information about the trial
Main objective of the trial	Primary Objectives: Part A To ascertain if the proposed dosing regimen of cholecalciferol achieves cancer-suppressive levels of 25(OH)D in Colorectal Cancer (CRC) patients. To investigate the safety of the cholecalciferol dose in CRC patients.
Protection of trial subjects	A Data Monitoring and Ethics Committee (DMEC) was appointed. The DMEC's responsibility was to safeguard the interests of the trial participants, in particular with regarding to safety and they advised the Trial Management Group so as to protect the validity and credibility of the trial.
Background therapy	-
Evidence for comparator	-
Actual start date of recruitment	20 Jan 2014
Long term follow-up planned	No
Independent data monitoring committee (IDMC) involvement?	Yes
Population of trial subjects
Number of subjects enrolled per country
Country: Number of subjects enrolled	United Kingdom: 30
Worldwide total number of subjects	30
EEA total number of subjects	30
Number of subjects enrolled per age group
In utero	0
Preterm newborn - gestational age < 37 wk	0
Newborns (0-27 days)	0
Infants and toddlers (28 days-23 months)	0
Children (2-11 years)	0
Adolescents (12-17 years)	0
Adults (18-64 years)	16
From 65 to 84 years	14
85 years and over	0

Trial information Top of page

Subject disposition Top of page
Recruitment
Recruitment details	30 patients were enrolled between 10th December 2013 and 20th March 2017. All patients were recruited from 1 site within the United Kingdom.
Pre-assignment
Screening details	A total of 228 patients were screened for eligibility in accordance with the study inclusion/exclusion criteria. 198 patients were found to be ineligible or declined to participate.
Period 1
Period 1 title	Part A Dose Confirmation (overall period)
Is this the baseline period?	Yes
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator, Monitor, Assessor
Blinding implementation details	Vigantol oil and the placebo oil were packaged and labeled in matching containers by Victoria Pharmaceuticals in Belfast according to the randomisation scheduled. Each bottle was labeled with a unique identifier and upon patient enrolment the medication packs were dispensed in sequential order starting with the lowest number available.
Arms
Are arms mutually exclusive	Yes
Arm title	Cholecalciferol 300,000 IU
Arm description	Single dose of 300, 000 IU cholecalciferol
Arm type	Experimental
Investigational medicinal product name	Cholecalciferol
Investigational medicinal product code
Other name
Pharmaceutical forms	Oral solution
Routes of administration	Oral use
Dosage and administration details	A single oral dose of cholecalciferol 300,000 IU on the morning of day 1. Participants were given 15 mL Vigantol oil (MERCK; cholecalciferol 20,000 IU/ml) to be taken by mouth after pre-treatment blood sampling. The study drug was taken with a glass of water and witnessed by a member of the research team.
Arm title	Placebo
Arm description	Single dose of Placebo liquid oil
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Oral liquid
Routes of administration	Oral use
Dosage and administration details	A single oral dose of placebo oil the morning of day 1. Participants were given 15 mL placebo oil, to be taken by mouth after pre-treatment blood sampling. The placebo oil was taken with a glass of water and witnessed by a member of the research team.
Arm title	Cholecalciferol 600,000 IU
Arm description	Single dose of 600, 000 IU cholecalciferol
Arm type	Increased Cholecalciferol Dose
Investigational medicinal product name	Cholecalciferol
Investigational medicinal product code
Other name
Pharmaceutical forms	Oral solution
Routes of administration	Oral use
Dosage and administration details	Single oral dose of cholecalciferol 600,000 IU on the morning of day 1. Participants were given 30 mL Vigantol oil (MERCK; cholecalciferol 20,000 IU/ml) to be taken by mouth after pre-treatment blood sampling. The study drug was taken with a glass of water and witnessed by a member of the research team.
Number of subjects in period 1 Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Started 10 10 10 Completed 10 10 10

Subject disposition Top of page

Baseline characteristics Top of page
Baseline characteristics reporting groups
Reporting group title	Cholecalciferol 300,000 IU
Reporting group description	Single dose of 300, 000 IU cholecalciferol
Reporting group title	Placebo
Reporting group description	Single dose of Placebo liquid oil
Reporting group title	Cholecalciferol 600,000 IU
Reporting group description	Single dose of 600, 000 IU cholecalciferol
Reporting group values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Total Number of subjects 10 10 10 30 Age categorical Units: Subjects     Adults (18-64 years) 8 6 2 16     From 65-84 years 2 4 8 14 Age continuous Age (years) Units: years     arithmetic mean (standard deviation) 57.2 ± 13.5 58.8 ± 13.4 69.9 ± 7.7 - Gender categorical Gender Units: Subjects     Female 3 3 2 8     Male 7 7 8 22 Height Height (cm) Units: cm     arithmetic mean (standard deviation) 170.6 ± 11.8 174.9 ± 12.6 175.6 ± 9.0 - Weight Weight (kg) Units: kilogram(s)     arithmetic mean (standard deviation) 92.4 ± 15.1 82.5 ± 16.8 83.2 ± 14.0 - Systolic Blood Pressure Systolic Blood Pressure (mm Hg) Units: mm Hg     arithmetic mean (standard deviation) 133.3 ± 17.3 130.6 ± 13.9 146.1 ± 17.8 - Diastolic Blood Pressure Diastolic Blood Pressure (mm Hg) Units: mm Hg     arithmetic mean (standard deviation) 80.0 ± 7.9 77.5 ± 5.6 81.8 ± 11.4 - Pulse Rate Pulse Rate Units: bpm     arithmetic mean (standard deviation) 75.0 ± 6.3 77.7 ± 15.8 68.5 ± 14.3 -

Baseline characteristics Top of page

End points Top of page
End points reporting groups
Reporting group title	Cholecalciferol 300,000 IU
Reporting group description	Single dose of 300, 000 IU cholecalciferol
Reporting group title	Placebo
Reporting group description	Single dose of Placebo liquid oil
Reporting group title	Cholecalciferol 600,000 IU
Reporting group description	Single dose of 600, 000 IU cholecalciferol

End points Top of page

Primary: 25(OH)D concentration in serum Baseline Top of page
End point title	25(OH)D concentration in serum Baseline [1]
End point description	25(OH)D concentration in serum
End point type	Primary
End point timeframe	Baseline
Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 9 10 Units: ng/mL     arithmetic mean (standard deviation) 19.52 ± 19.39 19.38 ± 9.25 15.84 ± 8.01
No statistical analyses for this end point

Primary: 25(OH)D concentration in serum Baseline Top of page

Primary: 25(OH)D concentration in serum Week 1 Top of page
End point title	25(OH)D concentration in serum Week 1 [2]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: ng/mL     arithmetic mean (standard deviation) 31.20 ± 17.54 18.68 ± 8.88 40.72 ± 15.41
No statistical analyses for this end point

Primary: 25(OH)D concentration in serum Week 1 Top of page

Primary: 25(OH)D concentration in serum Week 2 Top of page
End point title	25(OH)D concentration in serum Week 2 [3]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 8 10 Units: ng/mL     arithmetic mean (standard deviation) 32.80 ± 16.87 18.65 ± 4.67 39.96 ± 13.11
No statistical analyses for this end point

Primary: 25(OH)D concentration in serum Week 2 Top of page

Primary: 25(OH)D concentration in serum Week 3 Top of page
End point title	25(OH)D concentration in serum Week 3 [4]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: ng/mL     arithmetic mean (standard deviation) 36.09 ± 18.10 17.96 ± 8.57 38.48 ± 12.97
No statistical analyses for this end point

Primary: 25(OH)D concentration in serum Week 3 Top of page

Primary: 25(OH)D concentration in serum Week 4 Top of page
End point title	25(OH)D concentration in serum Week 4 [5]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 8 10 10 Units: ng/mL     arithmetic mean (standard deviation) 38.55 ± 17.44 18.28 ± 8.47 37.76 ± 11.68
No statistical analyses for this end point

Primary: 25(OH)D concentration in serum Week 4 Top of page

Primary: Haematology_Haemoglobin Baseline Top of page
End point title	Haematology_Haemoglobin Baseline [6]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: g/L     arithmetic mean (standard deviation) 146.20 ± 14.67 144.60 ± 13.98 147.20 ± 6.80
No statistical analyses for this end point

Primary: Haematology_Haemoglobin Baseline Top of page

Primary: Haematology_Haemoglobin Week 1 Top of page
End point title	Haematology_Haemoglobin Week 1 [7]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 9 10 Units: g/L     arithmetic mean (standard deviation) 147.90 ± 16.59 144.56 ± 14.82 145.50 ± 9.43
No statistical analyses for this end point

Primary: Haematology_Haemoglobin Week 1 Top of page

Primary: Haematology_Haemoglobin Week 2 Top of page
End point title	Haematology_Haemoglobin Week 2 [8]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: g/L     arithmetic mean (standard deviation) 148.20 ± 15.89 145.70 ± 16.95 146.60 ± 6.59
No statistical analyses for this end point

Primary: Haematology_Haemoglobin Week 2 Top of page

Primary: Haematology_Haemoglobin Week 3 Top of page
End point title	Haematology_Haemoglobin Week 3 [9]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: g/L     arithmetic mean (standard deviation) 145.33 ± 14.14 145.80 ± 16.56 145.20 ± 9.59
No statistical analyses for this end point

Primary: Haematology_Haemoglobin Week 3 Top of page

Primary: Haematology_Haemoglobin Week 4 Top of page
End point title	Haematology_Haemoglobin Week 4 [10]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: g/L     arithmetic mean (standard deviation) 147.80 ± 13.85 145.10 ± 14.63 145.00 ± 7.04
No statistical analyses for this end point

Primary: Haematology_Haemoglobin Week 4 Top of page

Primary: Haematology_Haematocrit Baseline Top of page
End point title	Haematology_Haematocrit Baseline [11]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: L/L     arithmetic mean (standard deviation) 0.42 ± 0.03 0.43 ± 0.04 0.43 ± 0.02
No statistical analyses for this end point

Primary: Haematology_Haematocrit Baseline Top of page

Primary: Haematology_Haematocrit Week 1 Top of page
End point title	Haematology_Haematocrit Week 1 [12]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 9 10 Units: L/L     arithmetic mean (standard deviation) 0.43 ± 0.03 0.43 ± 0.04 0.42 ± 0.02
No statistical analyses for this end point

Primary: Haematology_Haematocrit Week 1 Top of page

Primary: Haematology_Haematocrit Week 2 Top of page
End point title	Haematology_Haematocrit Week 2 [13]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: L/L     arithmetic mean (standard deviation) 0.43 ± 0.03 0.43 ± 0.05 0.43 ± 0.02
No statistical analyses for this end point

Primary: Haematology_Haematocrit Week 2 Top of page

Primary: Haematology_Haematocrit Week 3 Top of page
End point title	Haematology_Haematocrit Week 3 [14]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: L/L     arithmetic mean (standard deviation) 0.42 ± 0.03 0.43 ± 0.05 0.42 ± 0.02
No statistical analyses for this end point

Primary: Haematology_Haematocrit Week 3 Top of page

Primary: Haematology_Haematocrit Week 4 Top of page
End point title	Haematology_Haematocrit Week 4 [15]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: L/L     arithmetic mean (standard deviation) 0.43 ± 0.03 0.42 ± 0.04 0.42 ± 0.02
No statistical analyses for this end point

Primary: Haematology_Haematocrit Week 4 Top of page

Primary: Haematology_Platelets Baseline Top of page
End point title	Haematology_Platelets Baseline [16]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: 10^9/L     arithmetic mean (standard deviation) 211.60 ± 54.28 229.00 ± 51.08 182.40 ± 42.41
No statistical analyses for this end point

Primary: Haematology_Platelets Baseline Top of page

Primary: Haematology_Platelets Week 1 Top of page
End point title	Haematology_Platelets Week 1 [17]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 9 10 Units: 10^9/L     arithmetic mean (standard deviation) 207.30 ± 51.93 220.78 ± 56.40 185.50 ± 43.77
No statistical analyses for this end point

Primary: Haematology_Platelets Week 1 Top of page

Primary: Haematology_Platelets Week 2 Top of page
End point title	Haematology_Platelets Week 2 [18]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [18] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: X10^9/L     arithmetic mean (standard deviation) 213.20 ± 51.69 221.90 ± 42.89 187.10 ± 36.29
No statistical analyses for this end point

Primary: Haematology_Platelets Week 2 Top of page

Primary: Haematology_Platelets Week 3 Top of page
End point title	Haematology_Platelets Week 3 [19]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: 10^9/L     arithmetic mean (standard deviation) 215.56 ± 51.02 220.60 ± 36.79 188.00 ± 36.93
No statistical analyses for this end point

Primary: Haematology_Platelets Week 3 Top of page

Primary: Haematology_Platelets Week 4 Top of page
End point title	Haematology_Platelets Week 4 [20]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [20] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: 10^9/L     arithmetic mean (standard deviation) 214.30 ± 50.84 215.30 ± 45.93 188.00 ± 42.56
No statistical analyses for this end point

Primary: Haematology_Platelets Week 4 Top of page

Primary: Haematology_White Blood Cell Count Baseline Top of page
End point title	Haematology_White Blood Cell Count Baseline [21]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: 10^9/L     arithmetic mean (standard deviation) 6.21 ± 1.36 6.40 ± 2.04 6.07 ± 1.97
No statistical analyses for this end point

Primary: Haematology_White Blood Cell Count Baseline Top of page

Primary: Haematology_White Blood Cell Count Week 1 Top of page
End point title	Haematology_White Blood Cell Count Week 1 [22]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [22] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 9 10 Units: 10^9/L     arithmetic mean (standard deviation) 6.06 ± 1.33 5.66 ± 1.45 5.74 ± 1.96
No statistical analyses for this end point

Primary: Haematology_White Blood Cell Count Week 1 Top of page

Primary: Haematology_White Blood Cell Count Week 2 Top of page
End point title	Haematology_White Blood Cell Count Week 2 [23]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [23] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: 10^9/L     arithmetic mean (standard deviation) 6.17 ± 1.53 5.89 ± 1.46 6.24 ± 1.33
No statistical analyses for this end point

Primary: Haematology_White Blood Cell Count Week 2 Top of page

Primary: Haematology_White Blood Cell Count Week 3 Top of page
End point title	Haematology_White Blood Cell Count Week 3 [24]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [24] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: 10^9/L     arithmetic mean (standard deviation) 5.87 ± 1.58 5.73 ± 0.97 5.91 ± 1.56
No statistical analyses for this end point

Primary: Haematology_White Blood Cell Count Week 3 Top of page

Primary: Haematology_White Blood Cell Count Week 4 Top of page
End point title	Haematology_White Blood Cell Count Week 4 [25]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [25] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: 10^9/L     arithmetic mean (standard deviation) 5.90 ± 1.50 5.90 ± 1.15 6.02 ± 1.40
No statistical analyses for this end point

Primary: Haematology_White Blood Cell Count Week 4 Top of page

Primary: Haematology_Neutrophils Baseline Top of page
End point title	Haematology_Neutrophils Baseline [26]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [26] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: 10^9/L     arithmetic mean (standard deviation) 3.96 ± 1.21 4.07 ± 1.53 3.58 ± 1.50
No statistical analyses for this end point

Primary: Haematology_Neutrophils Baseline Top of page

Primary: Haematology_Neutrophils Week 1 Top of page
End point title	Haematology_Neutrophils Week 1 [27]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [27] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 9 10 Units: 10^9/L     arithmetic mean (standard deviation) 3.70 ± 1.23 3.23 ± 0.85 3.26 ± 1.24
No statistical analyses for this end point

Primary: Haematology_Neutrophils Week 1 Top of page

Primary: Haematology_Neutrophils Week 2 Top of page
End point title	Haematology_Neutrophils Week 2 [28]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [28] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: 10^9/L     arithmetic mean (standard deviation) 3.71 ± 1.32 3.45 ± 0.86 3.53 ± 0.98
No statistical analyses for this end point

Primary: Haematology_Neutrophils Week 2 Top of page

Primary: Haematology_Neutrophils Week 3 Top of page
End point title	Haematology_Neutrophils Week 3 [29]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [29] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: 10^9/L     arithmetic mean (standard deviation) 3.59 ± 1.25 3.32 ± 0.62 3.37 ± 1.01
No statistical analyses for this end point

Primary: Haematology_Neutrophils Week 3 Top of page

Primary: Haematology_Neutrophils Week 4 Top of page
End point title	Haematology_Neutrophils Week 4 [30]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [30] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: 10^9/L     arithmetic mean (standard deviation) 3.64 ± 1.20 3.60 ± 0.91 3.44 ± 0.81
No statistical analyses for this end point

Primary: Haematology_Neutrophils Week 4 Top of page

Primary: Haematology_Lymphocytes Baseline Top of page
End point title	Haematology_Lymphocytes Baseline [31]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [31] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: 10^9/L     arithmetic mean (standard deviation) 1.54 ± 0.48 1.62 ± 0.55 1.71 ± 0.47
No statistical analyses for this end point

Primary: Haematology_Lymphocytes Baseline Top of page

Primary: Haematology_Lymphocytes Week 1 Top of page
End point title	Haematology_Lymphocytes Week 1 [32]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [32] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 9 10 Units: 10^9/L     arithmetic mean (standard deviation) 1.63 ± 0.52 1.74 ± 0.77 1.77 ± 0.60
No statistical analyses for this end point

Primary: Haematology_Lymphocytes Week 1 Top of page

Primary: Haematology_Lymphocytes Week 2 Top of page
End point title	Haematology_Lymphocytes Week 2 [33]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [33] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: 10^9/L     arithmetic mean (standard deviation) 1.69 ± 0.41 1.70 ± 0.53 1.93 ± 0.56
No statistical analyses for this end point

Primary: Haematology_Lymphocytes Week 2 Top of page

Primary: Haematology_Lymphocytes Week 3 Top of page
End point title	Haematology_Lymphocytes Week 3 [34]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [34] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: 10^9/L     arithmetic mean (standard deviation) 1.57 ± 0.54 1.70 ± 0.45 1.77 ± 0.54
No statistical analyses for this end point

Primary: Haematology_Lymphocytes Week 3 Top of page

Primary: Haematology_Lymphocytes Week 4 Top of page
End point title	Haematology_Lymphocytes Week 4 [35]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [35] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: 10^9/L     arithmetic mean (standard deviation) 1.59 ± 0.56 1.59 ± 0.49 1.78 ± 0.53
No statistical analyses for this end point

Primary: Haematology_Lymphocytes Week 4 Top of page

Primary: Haematology_Monocytes Baseline Top of page
End point title	Haematology_Monocytes Baseline [36]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [36] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: 10^9/L     arithmetic mean (standard deviation) 0.53 ± 0.17 0.53 ± 0.15 0.56 ± 0.16
No statistical analyses for this end point

Primary: Haematology_Monocytes Baseline Top of page

Primary: Haematology_Monocytes Week 1 Top of page
End point title	Haematology_Monocytes Week 1 [37]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [37] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 9 10 Units: 10^9/L     arithmetic mean (standard deviation) 0.52 ± 0.14 0.48 ± 0.16 0.51 ± 0.19
No statistical analyses for this end point

Primary: Haematology_Monocytes Week 1 Top of page

Primary: Haematology_Monocytes Week 2 Top of page
End point title	Haematology_Monocytes Week 2 [38]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [38] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: 10^9/L     arithmetic mean (standard deviation) 0.54 ± 0.14 0.48 ± 0.14 0.53 ± 0.16
No statistical analyses for this end point

Primary: Haematology_Monocytes Week 2 Top of page

Primary: Haematology_Monocytes Week 3 Top of page
End point title	Haematology_Monocytes Week 3 [39]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [39] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: 10^9/L     arithmetic mean (standard deviation) 0.48 ± 0.19 0.49 ± 0.07 0.53 ± 0.21
No statistical analyses for this end point

Primary: Haematology_Monocytes Week 3 Top of page

Primary: Haematology_Monocytes Week 4 Top of page
End point title	Haematology_Monocytes Week 4 [40]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [40] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: 10^9/L     arithmetic mean (standard deviation) 0.49 ± 0.15 0.49 ± 0.17 0.57 ± 0.19
No statistical analyses for this end point

Primary: Haematology_Monocytes Week 4 Top of page

Primary: Haematology_Eosinophils Baseline Top of page
End point title	Haematology_Eosinophils Baseline [41]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [41] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: 10^9/L     arithmetic mean (standard deviation) 0.15 ± 0.14 0.18 ± 0.09 0.17 ± 0.09
No statistical analyses for this end point

Primary: Haematology_Eosinophils Baseline Top of page

Primary: Haematology_Eosinophils Week 1 Top of page
End point title	Haematology_Eosinophils Week 1 [42]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [42] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 9 10 Units: 10^9/L     arithmetic mean (standard deviation) 0.20 ± 0.13 0.18 ± 0.12 0.18 ± 0.09
No statistical analyses for this end point

Primary: Haematology_Eosinophils Week 1 Top of page

Primary: Haematology_Eosinophils Week 2 Top of page
End point title	Haematology_Eosinophils Week 2 [43]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [43] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: 10^9/L     arithmetic mean (standard deviation) 0.20 ± 0.12 0.20 ± 0.12 0.21 ± 0.10
No statistical analyses for this end point

Primary: Haematology_Eosinophils Week 2 Top of page

Primary: Haematology_Eosinophils Week 3 Top of page
End point title	Haematology_Eosinophils Week 3 [44]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [44] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: 10^9/L     arithmetic mean (standard deviation) 0.18 ± 0.15 0.20 ± 0.11 0.22 ± 0.12
No statistical analyses for this end point

Primary: Haematology_Eosinophils Week 3 Top of page

Primary: Haematology_Eosinophils Week 4 Top of page
End point title	Haematology_Eosinophils Week 4 [45]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [45] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: 10^9/L     arithmetic mean (standard deviation) 0.17 ± 0.16 0.18 ± 0.09 0.21 ± 0.11
No statistical analyses for this end point

Primary: Haematology_Eosinophils Week 4 Top of page

Primary: Haematology_Basophils Baseline Top of page
End point title	Haematology_Basophils Baseline [46]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [46] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: 10^9/L     arithmetic mean (standard deviation) 0.00 ± 0.00 0.02 ± 0.04 0.03 ± 0.02
No statistical analyses for this end point

Primary: Haematology_Basophils Baseline Top of page

Primary: Haematology_Basophils Week 1 Top of page
End point title	Haematology_Basophils Week 1 [47]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [47] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 9 10 Units: 10^9/L     arithmetic mean (standard deviation) 0.01 ± 0.03 0.01 ± 0.03 0.03 ± 0.02
No statistical analyses for this end point

Primary: Haematology_Basophils Week 1 Top of page

Primary: Haematology_Basophils Week 2 Top of page
End point title	Haematology_Basophils Week 2 [48]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [48] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: 10^9/L     arithmetic mean (standard deviation) 0.01 ± 0.03 0.01 ± 0.03 0.04 ± 0.02
No statistical analyses for this end point

Primary: Haematology_Basophils Week 2 Top of page

Primary: Haematology_Basophils Week 3 Top of page
End point title	Haematology_Basophils Week 3 [49]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [49] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: 10^9/L     arithmetic mean (standard deviation) 0.02 ± 0.04 0.01 ± 0.03 0.03 ± 0.02
No statistical analyses for this end point

Primary: Haematology_Basophils Week 3 Top of page

Primary: Haematology_Basophils Week 4 Top of page
End point title	Haematology_Basophils Week 4 [50]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [50] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: 10^9/L     arithmetic mean (standard deviation) 0.03 ± 0.05 0.01 ± 0.03 0.03 ± 0.02
No statistical analyses for this end point

Primary: Haematology_Basophils Week 4 Top of page

Primary: Biochemistry_Serum Calcium Baseline Top of page
End point title	Biochemistry_Serum Calcium Baseline [51]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [51] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: mmol/L     arithmetic mean (standard deviation) 2.36 ± 0.06 2.41 ± 0.11 2.37 ± 0.07
No statistical analyses for this end point

Primary: Biochemistry_Serum Calcium Baseline Top of page

Primary: Biochemistry_Serum Calcium Week 1 Top of page
End point title	Biochemistry_Serum Calcium Week 1 [52]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [52] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: mmol/L     arithmetic mean (standard deviation) 2.36 ± 0.06 2.39 ± 0.11 2.36 ± 0.06
No statistical analyses for this end point

Primary: Biochemistry_Serum Calcium Week 1 Top of page

Primary: Biochemistry_Serum Calcium Week 2 Top of page
End point title	Biochemistry_Serum Calcium Week 2 [53]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [53] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: mmol/L     arithmetic mean (standard deviation) 2.38 ± 0.06 2.42 ± 0.11 2.38 ± 0.07
No statistical analyses for this end point

Primary: Biochemistry_Serum Calcium Week 2 Top of page

Primary: Biochemistry_Serum Calcium Week 3 Top of page
End point title	Biochemistry_Serum Calcium Week 3 [54]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [54] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: mmol/L     arithmetic mean (standard deviation) 2.38 ± 0.07 2.38 ± 0.07 2.36 ± 0.06
No statistical analyses for this end point

Primary: Biochemistry_Serum Calcium Week 3 Top of page

Primary: Biochemistry_Serum Calcium Week 4 Top of page
End point title	Biochemistry_Serum Calcium Week 4 [55]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [55] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: mmol/L     arithmetic mean (standard deviation) 2.35 ± 0.09 2.39 ± 0.08 2.37 ± 0.07
No statistical analyses for this end point

Primary: Biochemistry_Serum Calcium Week 4 Top of page

Primary: Biochemistry_Corrected Serum Calcium Baseline Top of page
End point title	Biochemistry_Corrected Serum Calcium Baseline [56]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [56] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: mmol/L     arithmetic mean (standard deviation) 2.35 ± 0.06 2.38 ± 0.08 2.36 ± 0.08
No statistical analyses for this end point

Primary: Biochemistry_Corrected Serum Calcium Baseline Top of page

Primary: Biochemistry_Corrected Serum Calcium Week 1 Top of page
End point title	Biochemistry_Corrected Serum Calcium Week 1 [57]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [57] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: mmol/L     arithmetic mean (standard deviation) 2.37 ± 0.05 2.37 ± 0.08 2.38 ± 0.07
No statistical analyses for this end point

Primary: Biochemistry_Corrected Serum Calcium Week 1 Top of page

Primary: Biochemistry_Corrected Serum Calcium Week 2 Top of page
End point title	Biochemistry_Corrected Serum Calcium Week 2 [58]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [58] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: mmol/L     arithmetic mean (standard deviation) 2.37 ± 0.05 2.39 ± 0.08 2.40 ± 0.07
No statistical analyses for this end point

Primary: Biochemistry_Corrected Serum Calcium Week 2 Top of page

Primary: Biochemistry_Corrected Serum Calcium Week 3 Top of page
End point title	Biochemistry_Corrected Serum Calcium Week 3 [59]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [59] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: mmol/L     arithmetic mean (standard deviation) 2.37 ± 0.07 2.36 ± 0.06 2.38 ± 0.07
No statistical analyses for this end point

Primary: Biochemistry_Corrected Serum Calcium Week 3 Top of page

Primary: Biochemistry_Corrected Serum Calcium Week 4 Top of page
End point title	Biochemistry_Corrected Serum Calcium Week 4 [60]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [60] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: mmol/L     arithmetic mean (standard deviation) 2.33 ± 0.06 2.37 ± 0.07 2.38 ± 0.06
No statistical analyses for this end point

Primary: Biochemistry_Corrected Serum Calcium Week 4 Top of page

Primary: Biochemistry_Albumin Baseline Top of page
End point title	Biochemistry_Albumin Baseline [61]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [61] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: g/L     arithmetic mean (standard deviation) 44.60 ± 3.69 45.80 ± 2.70 44.70 ± 2.50
No statistical analyses for this end point

Primary: Biochemistry_Albumin Baseline Top of page

Primary: Biochemistry_Albumin Week 1 Top of page
End point title	Biochemistry_Albumin Week 1 [62]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [62] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: g/L     arithmetic mean (standard deviation) 43.50 ± 3.98 45.40 ± 2.59 42.90 ± 1.73
No statistical analyses for this end point

Primary: Biochemistry_Albumin Week 1 Top of page

Primary: Biochemistry_Albumin Week 2 Top of page
End point title	Biochemistry_Albumin Week 2 [63]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [63] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: g/L     arithmetic mean (standard deviation) 44.40 ± 2.99 45.60 ± 3.03 43.10 ± 1.85
No statistical analyses for this end point

Primary: Biochemistry_Albumin Week 2 Top of page

Primary: Biochemistry_Albumin Week 3 Top of page
End point title	Biochemistry_Albumin Week 3 [64]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [64] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: g/L     arithmetic mean (standard deviation) 44.67 ± 3.64 45.50 ± 2.46 43.00 ± 1.76
No statistical analyses for this end point

Primary: Biochemistry_Albumin Week 3 Top of page

Primary: Biochemistry_Albumin Week 4 Top of page
End point title	Biochemistry_Albumin Week 4 [65]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [65] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: g/L     arithmetic mean (standard deviation) 44.80 ± 2.86 45.60 ± 2.32 43.10 ± 1.97
No statistical analyses for this end point

Primary: Biochemistry_Albumin Week 4 Top of page

Primary: Biochemistry_Sodium Baseline Top of page
End point title	Biochemistry_Sodium Baseline [66]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [66] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: mmol/L     arithmetic mean (standard deviation) 140.90 ± 2.56 141.10 ± 2.02 140.40 ± 2.59
No statistical analyses for this end point

Primary: Biochemistry_Sodium Baseline Top of page

Primary: Biochemistry_Sodium Week 1 Top of page
End point title	Biochemistry_Sodium Week 1 [67]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [67] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: mmol/L     arithmetic mean (standard deviation) 141.80 ± 2.82 141.40 ± 1.71 141.20 ± 2.20
No statistical analyses for this end point

Primary: Biochemistry_Sodium Week 1 Top of page

Primary: Biochemistry_Sodium Week 2 Top of page
End point title	Biochemistry_Sodium Week 2 [68]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [68] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: mmol/L     arithmetic mean (standard deviation) 139.70 ± 2.79 141.40 ± 1.84 141.00 ± 1.49
No statistical analyses for this end point

Primary: Biochemistry_Sodium Week 2 Top of page

Primary: Biochemistry_Sodium Week 3 Top of page
End point title	Biochemistry_Sodium Week 3 [69]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [69] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: mmol/L     arithmetic mean (standard deviation) 140.89 ± 2.57 140.10 ± 2.08 141.00 ± 1.76
No statistical analyses for this end point

Primary: Biochemistry_Sodium Week 3 Top of page

Primary: Biochemistry_Sodium Week 4 Top of page
End point title	Biochemistry_Sodium Week 4 [70]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [70] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: mmol/L     arithmetic mean (standard deviation) 140.50 ± 2.17 140.70 ± 2.36 141.20 ± 2.20
No statistical analyses for this end point

Primary: Biochemistry_Sodium Week 4 Top of page

Primary: Biochemistry_Potassium Baseline Top of page
End point title	Biochemistry_Potassium Baseline [71]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [71] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: mmol/L     arithmetic mean (standard deviation) 4.22 ± 0.22 4.25 ± 0.38 4.54 ± 0.34
No statistical analyses for this end point

Primary: Biochemistry_Potassium Baseline Top of page

Primary: Biochemistry_Potassium Week 1 Top of page
End point title	Biochemistry_Potassium Week 1 [72]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [72] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: mmol/L     arithmetic mean (standard deviation) 4.16 ± 0.29 4.09 ± 0.16 4.18 ± 0.21
No statistical analyses for this end point

Primary: Biochemistry_Potassium Week 1 Top of page

Primary: Biochemistry_Potassium Week 2 Top of page
End point title	Biochemistry_Potassium Week 2 [73]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [73] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: mmol/L     arithmetic mean (standard deviation) 4.12 ± 0.25 4.17 ± 0.39 4.23 ± 0.25
No statistical analyses for this end point

Primary: Biochemistry_Potassium Week 2 Top of page

Primary: Biochemistry_Potassium Week 3 Top of page
End point title	Biochemistry_Potassium Week 3 [74]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [74] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: mmol/L     arithmetic mean (standard deviation) 4.07 ± 0.34 4.10 ± 0.13 4.28 ± 0.30
No statistical analyses for this end point

Primary: Biochemistry_Potassium Week 3 Top of page

Primary: Biochemistry_Potassium Week 4 Top of page
End point title	Biochemistry_Potassium Week 4 [75]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [75] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: mmol/L     arithmetic mean (standard deviation) 4.08 ± 0.34 4.07 ± 0.25 4.22 ± 0.23
No statistical analyses for this end point

Primary: Biochemistry_Potassium Week 4 Top of page

Primary: Biochemistry_Chloride Baseline Top of page
End point title	Biochemistry_Chloride Baseline [76]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [76] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: mmol/L     arithmetic mean (standard deviation) 104.10 ± 1.79 105.30 ± 1.57 102.40 ± 2.07
No statistical analyses for this end point

Primary: Biochemistry_Chloride Baseline Top of page

Primary: Biochemistry_Chloride Week 1 Top of page
End point title	Biochemistry_Chloride Week 1 [77]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [77] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: mmol/L     arithmetic mean (standard deviation) 106.10 ± 2.77 105.90 ± 1.66 102.40 ± 1.90
No statistical analyses for this end point

Primary: Biochemistry_Chloride Week 1 Top of page

Primary: Biochemistry_Chloride Week 2 Top of page
End point title	Biochemistry_Chloride Week 2 [78]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [78] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: mmol/L     arithmetic mean (standard deviation) 104.00 ± 2.54 106.40 ± 1.17 101.80 ± 1.23
No statistical analyses for this end point

Primary: Biochemistry_Chloride Week 2 Top of page

Primary: Biochemistry_Chloride Week 3 Top of page
End point title	Biochemistry_Chloride Week 3 [79]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [79] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: mmol/L     arithmetic mean (standard deviation) 104.67 ± 2.35 106.00 ± 1.94 102.30 ± 1.89
No statistical analyses for this end point

Primary: Biochemistry_Chloride Week 3 Top of page

Primary: Biochemistry_Chloride Week 4 Top of page
End point title	Biochemistry_Chloride Week 4 [80]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [80] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: mmol/L     arithmetic mean (standard deviation) 104.40 ± 2.50 106.10 ± 2.56 102.70 ± 2.00
No statistical analyses for this end point

Primary: Biochemistry_Chloride Week 4 Top of page

Primary: Biochemistry_Creatinine Baseline Top of page
End point title	Biochemistry_Creatinine Baseline [81]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [81] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: umol/L     arithmetic mean (standard deviation) 74.00 ± 12.29 78.50 ± 16.57 84.30 ± 15.56
No statistical analyses for this end point

Primary: Biochemistry_Creatinine Baseline Top of page

Primary: Biochemistry_Creatinine Week 1 Top of page
End point title	Biochemistry_Creatinine Week 1 [82]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [82] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: umol/L     arithmetic mean (standard deviation) 73.60 ± 12.70 77.60 ± 14.75 87.00 ± 17.16
No statistical analyses for this end point

Primary: Biochemistry_Creatinine Week 1 Top of page

Primary: Biochemistry_Creatinine Week 2 Top of page
End point title	Biochemistry_Creatinine Week 2 [83]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [83] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: umol/L     arithmetic mean (standard deviation) 76.60 ± 13.67 77.80 ± 14.45 89.60 ± 17.51
No statistical analyses for this end point

Primary: Biochemistry_Creatinine Week 2 Top of page

Primary: Biochemistry_Creatinine Week 3 Top of page
End point title	Biochemistry_Creatinine Week 3 [84]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [84] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: umol/L     arithmetic mean (standard deviation) 79.56 ± 12.26 80.50 ± 15.86 86.60 ± 17.48
No statistical analyses for this end point

Primary: Biochemistry_Creatinine Week 3 Top of page

Primary: Biochemistry_Creatinine Week 4 Top of page
End point title	Biochemistry_Creatinine Week 4 [85]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [85] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: umol/L     arithmetic mean (standard deviation) 73.40 ± 12.16 78.60 ± 15.32 86.30 ± 15.08
No statistical analyses for this end point

Primary: Biochemistry_Creatinine Week 4 Top of page

Primary: Biochemistry_Glucose, Serum Baseline Top of page
End point title	Biochemistry_Glucose, Serum Baseline [86]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [86] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: mmol/L     arithmetic mean (standard deviation) 6.99 ± 4.89 5.55 ± 0.61 5.99 ± 1.61
No statistical analyses for this end point

Primary: Biochemistry_Glucose, Serum Baseline Top of page

Primary: Biochemistry_Glucose, Serum Week 1 Top of page
End point title	Biochemistry_Glucose, Serum Week 1 [87]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [87] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: mmol/L     arithmetic mean (standard deviation) 6.93 ± 5.47 5.58 ± 0.92 6.44 ± 2.14
No statistical analyses for this end point

Primary: Biochemistry_Glucose, Serum Week 1 Top of page

Primary: Biochemistry_Glucose, Serum Week 2 Top of page
End point title	Biochemistry_Glucose, Serum Week 2 [88]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [88] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: mmol/L     arithmetic mean (standard deviation) 7.40 ± 5.43 5.69 ± 0.54 6.87 ± 1.80
No statistical analyses for this end point

Primary: Biochemistry_Glucose, Serum Week 2 Top of page

Primary: Biochemistry_Glucose, Serum Week 3 Top of page
End point title	Biochemistry_Glucose, Serum Week 3 [89]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [89] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: mmol/L     arithmetic mean (standard deviation) 8.57 ± 6.48 5.23 ± 0.45 6.68 ± 2.00
No statistical analyses for this end point

Primary: Biochemistry_Glucose, Serum Week 3 Top of page

Primary: Biochemistry_Glucose, Serum Week 4 Top of page
End point title	Biochemistry_Glucose, Serum Week 4 [90]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [90] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: mmol/L     arithmetic mean (standard deviation) 7.56 ± 5.53 5.35 ± 0.36 6.49 ± 2.01
No statistical analyses for this end point

Primary: Biochemistry_Glucose, Serum Week 4 Top of page

Primary: Biochemistry_Alkaline Phosphatase Baseline Top of page
End point title	Biochemistry_Alkaline Phosphatase Baseline [91]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [91] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: U/L     arithmetic mean (standard deviation) 91.30 ± 31.14 87.70 ± 22.75 112.20 ± 71.41
No statistical analyses for this end point

Primary: Biochemistry_Alkaline Phosphatase Baseline Top of page

Primary: Biochemistry_Alkaline Phosphatase Week 1 Top of page
End point title	Biochemistry_Alkaline Phosphatase Week 1 [92]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [92] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: U/L     arithmetic mean (standard deviation) 86.90 ± 23.46 88.20 ± 20.14 107.10 ± 76.27
No statistical analyses for this end point

Primary: Biochemistry_Alkaline Phosphatase Week 1 Top of page

Primary: Biochemistry_Alkaline Phosphatase Week 2 Top of page
End point title	Biochemistry_Alkaline Phosphatase Week 2 [93]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [93] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: U/L     arithmetic mean (standard deviation) 86.70 ± 24.82 86.60 ± 20.02 118.10 ± 106.36
No statistical analyses for this end point

Primary: Biochemistry_Alkaline Phosphatase Week 2 Top of page

Primary: Biochemistry_Alkaline Phosphatase Week 3 Top of page
End point title	Biochemistry_Alkaline Phosphatase Week 3 [94]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [94] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: U/L     arithmetic mean (standard deviation) 86.56 ± 22.25 83.40 ± 18.79 119.60 ± 119.65
No statistical analyses for this end point

Primary: Biochemistry_Alkaline Phosphatase Week 3 Top of page

Primary: Biochemistry_Alkaline Phosphatase Week 4 Top of page
End point title	Biochemistry_Alkaline Phosphatase Week 4 [95]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [95] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: U/L     arithmetic mean (standard deviation) 84.70 ± 21.80 84.70 ± 19.40 138.30 ± 171.89
No statistical analyses for this end point

Primary: Biochemistry_Alkaline Phosphatase Week 4 Top of page

Primary: Biochemistry_Blood Urea Baseline Top of page
End point title	Biochemistry_Blood Urea Baseline [96]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [96] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: mmol/L     arithmetic mean (standard deviation) 5.58 ± 1.37 4.28 ± 1.38 5.70 ± 1.33
No statistical analyses for this end point

Primary: Biochemistry_Blood Urea Baseline Top of page

Primary: Biochemistry_Blood Urea Week 1 Top of page
End point title	Biochemistry_Blood Urea Week 1 [97]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [97] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: mmol/L     arithmetic mean (standard deviation) 5.81 ± 1.60 4.63 ± 1.59 5.94 ± 1.31
No statistical analyses for this end point

Primary: Biochemistry_Blood Urea Week 1 Top of page

Primary: Biochemistry_Blood Urea Week 2 Top of page
End point title	Biochemistry_Blood Urea Week 2 [98]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [98] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: mmol/L     arithmetic mean (standard deviation) 5.25 ± 1.52 4.61 ± 1.31 6.16 ± 1.34
No statistical analyses for this end point

Primary: Biochemistry_Blood Urea Week 2 Top of page

Primary: Biochemistry_Blood Urea Week 3 Top of page
End point title	Biochemistry_Blood Urea Week 3 [99]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [99] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: mmol/L     arithmetic mean (standard deviation) 5.74 ± 1.68 4.76 ± 1.27 5.64 ± 1.16
No statistical analyses for this end point

Primary: Biochemistry_Blood Urea Week 3 Top of page

Primary: Biochemistry_Blood Urea Week 4 Top of page
End point title	Biochemistry_Blood Urea Week 4 [100]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [100] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: mmol/L     arithmetic mean (standard deviation) 5.30 ± 1.08 4.69 ± 1.41 6.16 ± 1.90
No statistical analyses for this end point

Primary: Biochemistry_Blood Urea Week 4 Top of page

Primary: Biochemistry_SGOT/AST Baseline Top of page
End point title	Biochemistry_SGOT/AST Baseline [101]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [101] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: U/L     arithmetic mean (standard deviation) 20.11 ± 5.01 24.40 ± 5.82 38.80 ± 48.78
No statistical analyses for this end point

Primary: Biochemistry_SGOT/AST Baseline Top of page

Primary: Biochemistry_SGOT/AST Week 1 Top of page
End point title	Biochemistry_SGOT/AST Week 1 [102]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [102] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: U/L     arithmetic mean (standard deviation) 20.44 ± 5.27 28.10 ± 13.26 30.90 ± 24.42
No statistical analyses for this end point

Primary: Biochemistry_SGOT/AST Week 1 Top of page

Primary: Biochemistry_SGOT/AST Week 2 Top of page
End point title	Biochemistry_SGOT/AST Week 2 [103]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [103] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: U/L     arithmetic mean (standard deviation) 21.80 ± 6.36 28.50 ± 12.62 35.30 ± 39.07
No statistical analyses for this end point

Primary: Biochemistry_SGOT/AST Week 2 Top of page

Primary: Biochemistry_SGOT/AST Week 3 Top of page
End point title	Biochemistry_SGOT/AST Week 3 [104]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [104] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: U/L     arithmetic mean (standard deviation) 20.44 ± 5.48 26.20 ± 9.40 27.80 ± 17.61
No statistical analyses for this end point

Primary: Biochemistry_SGOT/AST Week 3 Top of page

Primary: Biochemistry_SGOT/AST Week 4 Top of page
End point title	Biochemistry_SGOT/AST Week 4 [105]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [105] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: U/L     arithmetic mean (standard deviation) 22.10 ± 7.06 27.10 ± 10.45 38.20 ± 49.61
No statistical analyses for this end point

Primary: Biochemistry_SGOT/AST Week 4 Top of page

Primary: Biochemistry_SGPT/ALT Baseline Top of page
End point title	Biochemistry_SGPT/ALT Baseline [106]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [106] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: U/L     arithmetic mean (standard deviation) 27.10 ± 12.81 20.60 ± 7.59 36.50 ± 54.01
No statistical analyses for this end point

Primary: Biochemistry_SGPT/ALT Baseline Top of page

Primary: Biochemistry_SGPT/ALT Week 1 Top of page
End point title	Biochemistry_SGPT/ALT Week 1 [107]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [107] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: U/L     arithmetic mean (standard deviation) 25.30 ± 6.75 22.40 ± 11.73 30.50 ± 37.02
No statistical analyses for this end point

Primary: Biochemistry_SGPT/ALT Week 1 Top of page

Primary: Biochemistry_SGPT/ALT Week 2 Top of page
End point title	Biochemistry_SGPT/ALT Week 2 [108]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [108] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: U/L     arithmetic mean (standard deviation) 26.70 ± 8.31 24.30 ± 16.08 39.20 ± 63.83
No statistical analyses for this end point

Primary: Biochemistry_SGPT/ALT Week 2 Top of page

Primary: Biochemistry_SGPT/ALT Week 3 Top of page
End point title	Biochemistry_SGPT/ALT Week 3 [109]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [109] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: U/L     arithmetic mean (standard deviation) 25.11 ± 9.94 21.50 ± 9.58 29.60 ± 37.77
No statistical analyses for this end point

Primary: Biochemistry_SGPT/ALT Week 3 Top of page

Primary: Biochemistry_SGPT/ALT Week 4 Top of page
End point title	Biochemistry_SGPT/ALT Week 4 [110]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [110] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: U/L     arithmetic mean (standard deviation) 27.10 ± 13.64 23.00 ± 11.06 37.90 ± 62.84
No statistical analyses for this end point

Primary: Biochemistry_SGPT/ALT Week 4 Top of page

Primary: Biochemistry_Bilirubin, Total Baseline Top of page
End point title	Biochemistry_Bilirubin, Total Baseline [111]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [111] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: umol/L     arithmetic mean (standard deviation) 9.30 ± 5.77 10.30 ± 6.63 12.20 ± 4.59
No statistical analyses for this end point

Primary: Biochemistry_Bilirubin, Total Baseline Top of page

Primary: Biochemistry_Bilirubin, Total Week 1 Top of page
End point title	Biochemistry_Bilirubin, Total Week 1 [112]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [112] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: umol/L     arithmetic mean (standard deviation) 8.90 ± 4.09 10.60 ± 7.11 11.30 ± 3.30
No statistical analyses for this end point

Primary: Biochemistry_Bilirubin, Total Week 1 Top of page

Primary: Biochemistry_Bilirubin, Total Week 2 Top of page
End point title	Biochemistry_Bilirubin, Total Week 2 [113]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [113] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: umol/L     arithmetic mean (standard deviation) 10.00 ± 4.69 10.50 ± 6.75 13.20 ± 5.14
No statistical analyses for this end point

Primary: Biochemistry_Bilirubin, Total Week 2 Top of page

Primary: Biochemistry_Bilirubin, Total Week 3 Top of page
End point title	Biochemistry_Bilirubin, Total Week 3 [114]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [114] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: umol/L     arithmetic mean (standard deviation) 9.78 ± 5.56 11.50 ± 7.07 11.50 ± 4.84
No statistical analyses for this end point

Primary: Biochemistry_Bilirubin, Total Week 3 Top of page

Primary: Biochemistry_Bilirubin, Total Week 4 Top of page
End point title	Biochemistry_Bilirubin, Total Week 4 [115]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [115] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: umol/L     arithmetic mean (standard deviation) 10.00 ± 4.97 12.10 ± 7.13 12.00 ± 4.83
No statistical analyses for this end point

Primary: Biochemistry_Bilirubin, Total Week 4 Top of page

Primary: Biochemistry_Phosphorus Baseline Top of page
End point title	Biochemistry_Phosphorus Baseline [116]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [116] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: mmol/L     arithmetic mean (standard deviation) 1.05 ± 0.18 0.97 ± 0.18 0.86 ± 0.17
No statistical analyses for this end point

Primary: Biochemistry_Phosphorus Baseline Top of page

Primary: Biochemistry_Phosphorus Week 1 Top of page
End point title	Biochemistry_Phosphorus Week 1 [117]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [117] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: mmol/L     arithmetic mean (standard deviation) 1.01 ± 0.14 0.94 ± 0.20 0.86 ± 0.19
No statistical analyses for this end point

Primary: Biochemistry_Phosphorus Week 1 Top of page

Primary: Biochemistry_Phosphorus Week 2 Top of page
End point title	Biochemistry_Phosphorus Week 2 [118]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [118] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: mmol/L     arithmetic mean (standard deviation) 1.02 ± 0.19 0.93 ± 0.22 0.86 ± 0.20
No statistical analyses for this end point

Primary: Biochemistry_Phosphorus Week 2 Top of page

Primary: Biochemistry_Phosphorus Week 3 Top of page
End point title	Biochemistry_Phosphorus Week 3 [119]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [119] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: mmol/L     arithmetic mean (standard deviation) 1.02 ± 0.13 0.92 ± 0.19 0.82 ± 0.18
No statistical analyses for this end point

Primary: Biochemistry_Phosphorus Week 3 Top of page

Primary: Biochemistry_Phosphorus Week 4 Top of page
End point title	Biochemistry_Phosphorus Week 4 [120]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [120] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: mmol/L     arithmetic mean (standard deviation) 1.04 ± 0.18 0.92 ± 0.20 0.84 ± 0.18
No statistical analyses for this end point

Primary: Biochemistry_Phosphorus Week 4 Top of page

Primary: Biochemistry_eGFR Baseline Top of page
End point title	Biochemistry_eGFR Baseline [121]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [121] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: mL/min     arithmetic mean (standard deviation) 60.00 ± 0.00 60.00 ± 0.00 62.50 ± 6.10
No statistical analyses for this end point

Primary: Biochemistry_eGFR Baseline Top of page

Primary: Biochemistry_eGFR Week 1 Top of page
End point title	Biochemistry_eGFR Week 1 [122]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [122] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: mL/min     arithmetic mean (standard deviation) 60.00 ± 0.00 60.00 ± 0.00 59.30 ± 1.89
No statistical analyses for this end point

Primary: Biochemistry_eGFR Week 1 Top of page

Primary: Biochemistry_eGFR Week 2 Top of page
End point title	Biochemistry_eGFR Week 2 [123]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [123] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: mL/min     arithmetic mean (standard deviation) 60.00 ± 0.00 60.00 ± 0.00 58.50 ± 2.55
No statistical analyses for this end point

Primary: Biochemistry_eGFR Week 2 Top of page

Primary: Biochemistry_eGFR Week 3 Top of page
End point title	Biochemistry_eGFR Week 3 [124]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [124] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: mL/min     arithmetic mean (standard deviation) 60.00 ± 0.00 59.80 ± 0.63 59.20 ± 2.20
No statistical analyses for this end point

Primary: Biochemistry_eGFR Week 3 Top of page

Primary: Biochemistry_eGFR Week 4 Top of page
End point title	Biochemistry_eGFR Week 4 [125]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [125] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: mL/min     arithmetic mean (standard deviation) 60.00 ± 0.00 60.00 ± 0.00 59.40 ± 1.58
No statistical analyses for this end point

Primary: Biochemistry_eGFR Week 4 Top of page

Primary: Serum 25(OH)D >/= 33 ng/mL Baseline Top of page
End point title	Serum 25(OH)D >/= 33 ng/mL Baseline [126]
End point description	Number of patients with a serum 25(OH)D concentration of greater than or equal to 33 ng/mL
End point type	Primary
End point timeframe	Baseline
Notes [126] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 9 10 Units: Patients 1 1 0
No statistical analyses for this end point

Primary: Serum 25(OH)D >/= 33 ng/mL Baseline Top of page

Primary: Serum 25(OH)D >/= 33 ng/mL Week 1 Top of page
End point title	Serum 25(OH)D >/= 33 ng/mL Week 1 [127]
End point description	Number of patients with serum 25(OH)D concentrations greater than or equal to 33 ng/mL
End point type	Primary
End point timeframe	Week 1
Notes [127] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: Patients 5 1 7
No statistical analyses for this end point

Primary: Serum 25(OH)D >/= 33 ng/mL Week 1 Top of page

Primary: Serum 25(OH)D >/= 33 ng/mL Week 2 Top of page
End point title	Serum 25(OH)D >/= 33 ng/mL Week 2 [128]
End point description	Number of patients with serum 25(OH)D concentration greater than or equal to 33 ng/mL
End point type	Primary
End point timeframe	Week 2
Notes [128] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 8 10 Units: Patients 5 0 7
No statistical analyses for this end point

Primary: Serum 25(OH)D >/= 33 ng/mL Week 2 Top of page

Primary: Serum 25(OH)D >/= 33 ng/mL Week 3 Top of page
End point title	Serum 25(OH)D >/= 33 ng/mL Week 3 [129]
End point description	Number of patients with serum 25(OH)D concentration greater than or equal to 33 ng/mL
End point type	Primary
End point timeframe	Week 3
Notes [129] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: Patients 5 1 7
No statistical analyses for this end point

Primary: Serum 25(OH)D >/= 33 ng/mL Week 3 Top of page

Primary: Serum 25(OH)D >/= 33 ng/mL Week 4 Top of page
End point title	Serum 25(OH)D >/= 33 ng/mL Week 4 [130]
End point description	Number of patients with serum 25(OH)D concentration greater than or equal to 33 ng/mL
End point type	Primary
End point timeframe	Week 4
Notes [130] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 8 10 10 Units: Patients 5 0 7
No statistical analyses for this end point

Primary: Serum 25(OH)D >/= 33 ng/mL Week 4 Top of page

Primary: Serum corrected Calcium >/= 2.65mmol/I Baseline Top of page
End point title	Serum corrected Calcium >/= 2.65mmol/I Baseline [131]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [131] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 0 0 0
No statistical analyses for this end point

Primary: Serum corrected Calcium >/= 2.65mmol/I Baseline Top of page

Primary: Falls_Has fallen in the last week Baseline Top of page
End point title	Falls_Has fallen in the last week Baseline [132]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [132] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 1 0 0
No statistical analyses for this end point

Primary: Falls_Has fallen in the last week Baseline Top of page

Primary: Falls_Has fallen in the last week Week 2 Top of page
End point title	Falls_Has fallen in the last week Week 2 [133]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [133] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 1 0 0
No statistical analyses for this end point

Primary: Falls_Has fallen in the last week Week 2 Top of page

Primary: Falls_Has fallen in the last week Week 3 Top of page
End point title	Falls_Has fallen in the last week Week 3 [134]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [134] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: Patients 0 0 0
No statistical analyses for this end point

Primary: Falls_Has fallen in the last week Week 3 Top of page

Primary: Falls_Has fallen in the last week Week 4 Top of page
End point title	Falls_Has fallen in the last week Week 4 [135]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [135] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 1 0 0
No statistical analyses for this end point

Primary: Falls_Has fallen in the last week Week 4 Top of page

Primary: Serum corrected Calcium >/= 2.65mmol/I Week 1 Top of page
End point title	Serum corrected Calcium >/= 2.65mmol/I Week 1 [136]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [136] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 0 0 0
No statistical analyses for this end point

Primary: Serum corrected Calcium >/= 2.65mmol/I Week 1 Top of page

Primary: Serum corrected Calcium >/= 2.65mmol/I Week 2 Top of page
End point title	Serum corrected Calcium >/= 2.65mmol/I Week 2 [137]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [137] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 0 0 0
No statistical analyses for this end point

Primary: Serum corrected Calcium >/= 2.65mmol/I Week 2 Top of page

Primary: Serum corrected Calcium >/= 2.65mmol/I Week 3 Top of page
End point title	Serum corrected Calcium >/= 2.65mmol/I Week 3 [138]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [138] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: Patient 0 0 0
No statistical analyses for this end point

Primary: Serum corrected Calcium >/= 2.65mmol/I Week 3 Top of page

Primary: Serum corrected Calcium >/= 2.65mmol/I Week 4 Top of page
End point title	Serum corrected Calcium >/= 2.65mmol/I Week 4 [139]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [139] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 0 0 0
No statistical analyses for this end point

Primary: Serum corrected Calcium >/= 2.65mmol/I Week 4 Top of page

Primary: Falls_Times fallen in the last week Baseline Top of page
End point title	Falls_Times fallen in the last week Baseline [140] [141]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [140] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. [141] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Number of subjects analysed 1 Units: Times Fallen 1
No statistical analyses for this end point

Primary: Falls_Times fallen in the last week Baseline Top of page

Primary: Falls_Times fallen in the last week Week 2 Top of page
End point title	Falls_Times fallen in the last week Week 2 [142] [143]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [142] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. [143] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Number of subjects analysed 1 Units: Times Fallen 1
No statistical analyses for this end point

Primary: Falls_Times fallen in the last week Week 2 Top of page

Primary: Falls_Times fallen in the last week Week 4 Top of page
End point title	Falls_Times fallen in the last week Week 4 [144] [145]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [144] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. [145] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Number of subjects analysed 1 Units: Times Fallen 1
No statistical analyses for this end point

Primary: Falls_Times fallen in the last week Week 4 Top of page

Primary: Diet_Other Vitamins Baseline Top of page
End point title	Diet_Other Vitamins Baseline [146]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [146] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 1 0 0
No statistical analyses for this end point

Primary: Diet_Other Vitamins Baseline Top of page

Primary: Diet_Other Vitamins Week 1 Top of page
End point title	Diet_Other Vitamins Week 1 [147]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [147] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: Patients 0 0 0
No statistical analyses for this end point

Primary: Diet_Other Vitamins Week 1 Top of page

Primary: Diet_Other Vitamins Week 2 Top of page
End point title	Diet_Other Vitamins Week 2 [148]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [148] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: Patients 1 0 0
No statistical analyses for this end point

Primary: Diet_Other Vitamins Week 2 Top of page

Primary: Diet_Other Vitamins Week 3 Top of page
End point title	Diet_Other Vitamins Week 3 [149]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [149] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: Patients 1 0 0
No statistical analyses for this end point

Primary: Diet_Other Vitamins Week 3 Top of page

Primary: Diet_Other Vitamins Week 4 Top of page
End point title	Diet_Other Vitamins Week 4 [150]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [150] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 1 0 0
No statistical analyses for this end point

Primary: Diet_Other Vitamins Week 4 Top of page

Primary: Diet_Fish Oil Baseline Top of page
End point title	Diet_Fish Oil Baseline [151]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [151] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 0 0 1
No statistical analyses for this end point

Primary: Diet_Fish Oil Baseline Top of page

Primary: Diet_Fish Oil Week 1 Top of page
End point title	Diet_Fish Oil Week 1 [152]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [152] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 0 0 0
No statistical analyses for this end point

Primary: Diet_Fish Oil Week 1 Top of page

Primary: Diet_Fish Oil Week 2 Top of page
End point title	Diet_Fish Oil Week 2 [153]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [153] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 0 0 0
No statistical analyses for this end point

Primary: Diet_Fish Oil Week 2 Top of page

Primary: Diet_Fish Oil Week 3 Top of page
End point title	Diet_Fish Oil Week 3 [154]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [154] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: Patients 0 0 0
No statistical analyses for this end point

Primary: Diet_Fish Oil Week 3 Top of page

Primary: Diet_Fish Oil Week 4 Top of page
End point title	Diet_Fish Oil Week 4 [155]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [155] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 0 0 0
No statistical analyses for this end point

Primary: Diet_Fish Oil Week 4 Top of page

Primary: Falls_Location Baseline Top of page
End point title	Falls_Location Baseline [156] [157]
End point description	Inside the house
End point type	Primary
End point timeframe	Baseline
Notes [156] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. [157] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Number of subjects analysed 1 Units: Times Fallen 1
No statistical analyses for this end point

Primary: Falls_Location Baseline Top of page

Primary: Falls_Location Baseline Top of page
End point title	Falls_Location Baseline [158] [159]
End point description	Inside house_walking up/down stairs
End point type	Primary
End point timeframe	Baseline
Notes [158] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. [159] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Number of subjects analysed 1 Units: Times Fallen 1
No statistical analyses for this end point

Primary: Falls_Location Baseline Top of page

Primary: Falls_Location Baseline Top of page
End point title	Falls_Location Baseline [160] [161]
End point description	Home entrance/in garden
End point type	Primary
End point timeframe	Baseline
Notes [160] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. [161] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Number of subjects analysed 1 Units: Times Fallen 0
No statistical analyses for this end point

Primary: Falls_Location Baseline Top of page

Primary: Falls_Location Baseline Top of page
End point title	Falls_Location Baseline [162] [163]
End point description	Away from home
End point type	Primary
End point timeframe	Baseline
Notes [162] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. [163] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Number of subjects analysed 1 Units: Times Fallen 0
No statistical analyses for this end point

Primary: Falls_Location Baseline Top of page

Primary: Falls_Location Week 2 Top of page
End point title	Falls_Location Week 2 [164] [165]
End point description	Inside the house
End point type	Primary
End point timeframe	Week 2
Notes [164] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. [165] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Number of subjects analysed 1 Units: Times Fallen 0
No statistical analyses for this end point

Primary: Falls_Location Week 2 Top of page

Primary: Falls_Location Week 2 Top of page
End point title	Falls_Location Week 2 [166] [167]
End point description	Home entrance/in garden
End point type	Primary
End point timeframe	Week 2
Notes [166] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. [167] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Number of subjects analysed 1 Units: Times Fallen 1
No statistical analyses for this end point

Primary: Falls_Location Week 2 Top of page

Primary: Falls_Location Week 2 Top of page
End point title	Falls_Location Week 2 [168] [169]
End point description	Home entrance/in garden_In the garden
End point type	Primary
End point timeframe	Week 2
Notes [168] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. [169] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Number of subjects analysed 1 Units: Times Fallen 1
No statistical analyses for this end point

Primary: Falls_Location Week 2 Top of page

Primary: Falls_Location Week 2 Top of page
End point title	Falls_Location Week 2 [170] [171]
End point description	Away from home
End point type	Primary
End point timeframe	Week 2
Notes [170] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. [171] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Number of subjects analysed 1 Units: Times Fallen 0
No statistical analyses for this end point

Primary: Falls_Location Week 2 Top of page

Primary: Falls_Location Week 4 Top of page
End point title	Falls_Location Week 4 [172] [173]
End point description	Inside the house
End point type	Primary
End point timeframe	Week 4
Notes [172] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. [173] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Number of subjects analysed 1 Units: Times Fallen 0
No statistical analyses for this end point

Primary: Falls_Location Week 4 Top of page

Primary: Falls_Location Week 4 Top of page
End point title	Falls_Location Week 4 [174] [175]
End point description	Home entrance/in garden
End point type	Primary
End point timeframe	Week 4
Notes [174] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. [175] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Number of subjects analysed 1 Units: Times Fallen 0
No statistical analyses for this end point

Primary: Falls_Location Week 4 Top of page

Primary: Falls_Location Week 4 Top of page
End point title	Falls_Location Week 4 [176] [177]
End point description	Away from home
End point type	Primary
End point timeframe	Week 4
Notes [176] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. [177] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Number of subjects analysed 1 Units: Times Fallen 0
No statistical analyses for this end point

Primary: Falls_Location Week 4 Top of page

Primary: Falls_Location Week 4 Top of page
End point title	Falls_Location Week 4 [178] [179]
End point description	Away from home_On a kerb/gutter
End point type	Primary
End point timeframe	Week 4
Notes [178] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. [179] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Number of subjects analysed 1 Units: Times Fallen 1
No statistical analyses for this end point

Primary: Falls_Location Week 4 Top of page

Primary: Falls_Injured as a result Baseline Top of page
End point title	Falls_Injured as a result Baseline [180] [181]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [180] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. [181] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Number of subjects analysed 1 Units: Patients 0
No statistical analyses for this end point

Primary: Falls_Injured as a result Baseline Top of page

Primary: Falls_Injured as a result Week 2 Top of page
End point title	Falls_Injured as a result Week 2 [182] [183]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [182] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. [183] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Number of subjects analysed 1 Units: Patients 0
No statistical analyses for this end point

Primary: Falls_Injured as a result Week 2 Top of page

Primary: Falls_Injured as a result Week 4 Top of page
End point title	Falls_Injured as a result Week 4 [184] [185]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [184] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. [185] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Number of subjects analysed 1 Units: Patients 0
No statistical analyses for this end point

Primary: Falls_Injured as a result Week 4 Top of page

Primary: Diet_Times per week eat oily fish Baseline Top of page
End point title	Diet_Times per week eat oily fish Baseline [186]
End point description	None
End point type	Primary
End point timeframe	Baseline
Notes [186] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Times Per Week 4 7 5
No statistical analyses for this end point

Primary: Diet_Times per week eat oily fish Baseline Top of page

Primary: Diet_Times per week eat oily fish Baseline Top of page
End point title	Diet_Times per week eat oily fish Baseline [187]
End point description	Once
End point type	Primary
End point timeframe	Baseline
Notes [187] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Times Per Week 1 2 2
No statistical analyses for this end point

Primary: Diet_Times per week eat oily fish Baseline Top of page

Primary: Diet_Times per week eat oily fish Baseline Top of page
End point title	Diet_Times per week eat oily fish Baseline [188]
End point description	Twice
End point type	Primary
End point timeframe	Baseline
Notes [188] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Times Per Week 1 1 3
No statistical analyses for this end point

Primary: Diet_Times per week eat oily fish Baseline Top of page

Primary: Diet_Times per week eat oily fish Baseline Top of page
End point title	Diet_Times per week eat oily fish Baseline [189]
End point description	Three or More
End point type	Primary
End point timeframe	Baseline
Notes [189] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Times Per Week 0 0 0
No statistical analyses for this end point

Primary: Diet_Times per week eat oily fish Baseline Top of page

Primary: Diet_Times per week eat oily fish Week 1 Top of page
End point title	Diet_Times per week eat oily fish Week 1 [190]
End point description	None
End point type	Primary
End point timeframe	Week 1
Notes [190] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Times Per Week 10 10 10
No statistical analyses for this end point

Primary: Diet_Times per week eat oily fish Week 1 Top of page

Primary: Diet_Times per week eat oily fish Week 1 Top of page
End point title	Diet_Times per week eat oily fish Week 1 [191]
End point description	Once
End point type	Primary
End point timeframe	Week 1
Notes [191] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Times Per Week 0 0 0
No statistical analyses for this end point

Primary: Diet_Times per week eat oily fish Week 1 Top of page

Primary: Diet_Times per week eat oily fish Week 1 Top of page
End point title	Diet_Times per week eat oily fish Week 1 [192]
End point description	Twice
End point type	Primary
End point timeframe	Week 1
Notes [192] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Timee Per Week 0 0 0
No statistical analyses for this end point

Primary: Diet_Times per week eat oily fish Week 1 Top of page

Primary: Diet_Times per week eat oily fish Week 1 Top of page
End point title	Diet_Times per week eat oily fish Week 1 [193]
End point description	Three or more
End point type	Primary
End point timeframe	Week 1
Notes [193] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Times Per Week 0 0 0
No statistical analyses for this end point

Primary: Diet_Times per week eat oily fish Week 1 Top of page

Primary: Diet_Times per week eat oily fish Week 2 Top of page
End point title	Diet_Times per week eat oily fish Week 2 [194]
End point description	None
End point type	Primary
End point timeframe	Week 2
Notes [194] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Times Per Week 10 10 10
No statistical analyses for this end point

Primary: Diet_Times per week eat oily fish Week 2 Top of page

Primary: Diet_Times per week eat oily fish Week 2 Top of page
End point title	Diet_Times per week eat oily fish Week 2 [195]
End point description	Once
End point type	Primary
End point timeframe	Week 2
Notes [195] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Times Per Week 0 0 0
No statistical analyses for this end point

Primary: Diet_Times per week eat oily fish Week 2 Top of page

Primary: Diet_Times per week eat oily fish Week 2 Top of page
End point title	Diet_Times per week eat oily fish Week 2 [196]
End point description	Twice
End point type	Primary
End point timeframe	Week 2
Notes [196] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Times Per Week 0 0 0
No statistical analyses for this end point

Primary: Diet_Times per week eat oily fish Week 2 Top of page

Primary: Diet_Times per week eat oily fish Week 2 Top of page
End point title	Diet_Times per week eat oily fish Week 2 [197]
End point description	Three or more
End point type	Primary
End point timeframe	Week 2
Notes [197] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Times Per Week 0 0 0
No statistical analyses for this end point

Primary: Diet_Times per week eat oily fish Week 2 Top of page

Primary: Diet_Times per week eat oily fish Week 3 Top of page
End point title	Diet_Times per week eat oily fish Week 3 [198]
End point description	None
End point type	Primary
End point timeframe	Week 3
Notes [198] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: Times Per Week 9 10 9
No statistical analyses for this end point

Primary: Diet_Times per week eat oily fish Week 3 Top of page

Primary: Diet_Times per week eat oily fish Week 3 Top of page
End point title	Diet_Times per week eat oily fish Week 3 [199]
End point description	Once
End point type	Primary
End point timeframe	Week 3
Notes [199] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: Times Per Week 0 0 1
No statistical analyses for this end point

Primary: Diet_Times per week eat oily fish Week 3 Top of page

Primary: Diet_Times per week eat oily fish Week 3 Top of page
End point title	Diet_Times per week eat oily fish Week 3 [200]
End point description	Twice
End point type	Primary
End point timeframe	Week 3
Notes [200] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: Times Per Week 0 0 0
No statistical analyses for this end point

Primary: Diet_Times per week eat oily fish Week 3 Top of page

Primary: Diet_Times per week eat oily fish Week 3 Top of page
End point title	Diet_Times per week eat oily fish Week 3 [201]
End point description	Three or more
End point type	Primary
End point timeframe	Week 3
Notes [201] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: Times Per Week 0 0 0
No statistical analyses for this end point

Primary: Diet_Times per week eat oily fish Week 3 Top of page

Primary: Diet_Times per week eat oily fish Week 4 Top of page
End point title	Diet_Times per week eat oily fish Week 4 [202]
End point description	None
End point type	Primary
End point timeframe	Week 4
Notes [202] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 9 Units: Times Per Week 9 10 8
No statistical analyses for this end point

Primary: Diet_Times per week eat oily fish Week 4 Top of page

Primary: Diet_Times per week eat oily fish Week 4 Top of page
End point title	Diet_Times per week eat oily fish Week 4 [203]
End point description	Once
End point type	Primary
End point timeframe	Week 4
Notes [203] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 9 Units: Times Per Week 0 0 1
No statistical analyses for this end point

Primary: Diet_Times per week eat oily fish Week 4 Top of page

Primary: Diet_Times per week eat oily fish Week 4 Top of page
End point title	Diet_Times per week eat oily fish Week 4 [204]
End point description	Twice
End point type	Primary
End point timeframe	Week 4
Notes [204] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 9 Units: Diet_Times per week eat oily fish 0 0 0
No statistical analyses for this end point

Primary: Diet_Times per week eat oily fish Week 4 Top of page

Primary: Diet_Times per week eat oily fish Week 4 Top of page
End point title	Diet_Times per week eat oily fish Week 4 [205]
End point description	Three or more
End point type	Primary
End point timeframe	Week 4
Notes [205] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 9 Units: Times Per Week 0 0 0
No statistical analyses for this end point

Primary: Diet_Times per week eat oily fish Week 4 Top of page

Primary: Diet_Times per week eat mushrooms Baseline Top of page
End point title	Diet_Times per week eat mushrooms Baseline [206]
End point description	None
End point type	Primary
End point timeframe	Baseline
Notes [206] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Times per week 4 2 4
No statistical analyses for this end point

Primary: Diet_Times per week eat mushrooms Baseline Top of page

Primary: Diet_Times per week eat mushrooms Baseline Top of page
End point title	Diet_Times per week eat mushrooms Baseline [207]
End point description	Once
End point type	Primary
End point timeframe	Baseline
Notes [207] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Times Per Week 2 4 4
No statistical analyses for this end point

Primary: Diet_Times per week eat mushrooms Baseline Top of page

Primary: Diet_Times per week eat mushrooms Baseline Top of page
End point title	Diet_Times per week eat mushrooms Baseline [208]
End point description	Twice
End point type	Primary
End point timeframe	Baseline
Notes [208] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Times Per Week 3 2 2
No statistical analyses for this end point

Primary: Diet_Times per week eat mushrooms Baseline Top of page

Primary: Diet_Times per week eat mushrooms Baseline Top of page
End point title	Diet_Times per week eat mushrooms Baseline [209]
End point description	Three or more
End point type	Primary
End point timeframe	Baseline
Notes [209] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Times Per Week 1 2 0
No statistical analyses for this end point

Primary: Diet_Times per week eat mushrooms Baseline Top of page

Primary: Diet_Times per week eat mushrooms Week 1 Top of page
End point title	Diet_Times per week eat mushrooms Week 1 [210]
End point description	None
End point type	Primary
End point timeframe	Week 1
Notes [210] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Times Per Week 10 9 8
No statistical analyses for this end point

Primary: Diet_Times per week eat mushrooms Week 1 Top of page

Primary: Diet_Times per week eat mushrooms Week 1 Top of page
End point title	Diet_Times per week eat mushrooms Week 1 [211]
End point description	Once
End point type	Primary
End point timeframe	Week 1
Notes [211] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Times Per Week 0 0 2
No statistical analyses for this end point

Primary: Diet_Times per week eat mushrooms Week 1 Top of page

Primary: Diet_Times per week eat mushrooms Week 1 Top of page
End point title	Diet_Times per week eat mushrooms Week 1 [212]
End point description	Twice
End point type	Primary
End point timeframe	Week 1
Notes [212] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Times Per Week 0 0 0
No statistical analyses for this end point

Primary: Diet_Times per week eat mushrooms Week 1 Top of page

Primary: Diet_Times per week eat mushrooms Week 1 Top of page
End point title	Diet_Times per week eat mushrooms Week 1 [213]
End point description	Three of more
End point type	Primary
End point timeframe	Week 1
Notes [213] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Times Per Week 0 1 0
No statistical analyses for this end point

Primary: Diet_Times per week eat mushrooms Week 1 Top of page

Primary: Diet_Times per week eat mushrooms Week 2 Top of page
End point title	Diet_Times per week eat mushrooms Week 2 [214]
End point description	None
End point type	Primary
End point timeframe	Week 2
Notes [214] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Times Per Week 9 8 10
No statistical analyses for this end point

Primary: Diet_Times per week eat mushrooms Week 2 Top of page

Primary: Diet_Times per week eat mushrooms Week 2 Top of page
End point title	Diet_Times per week eat mushrooms Week 2 [215]
End point description	Once
End point type	Primary
End point timeframe	Week 2
Notes [215] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Times Per Week 1 1 0
No statistical analyses for this end point

Primary: Diet_Times per week eat mushrooms Week 2 Top of page

Primary: Diet_Times per week eat mushrooms Week 2 Top of page
End point title	Diet_Times per week eat mushrooms Week 2 [216]
End point description	Twice
End point type	Primary
End point timeframe	Week 2
Notes [216] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Times Per Week 0 0 0
No statistical analyses for this end point

Primary: Diet_Times per week eat mushrooms Week 2 Top of page

Primary: Diet_Times per week eat mushrooms Week 2 Top of page
End point title	Diet_Times per week eat mushrooms Week 2 [217]
End point description	Three or more
End point type	Primary
End point timeframe	Week 2
Notes [217] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Times Per Week 0 1 0
No statistical analyses for this end point

Primary: Diet_Times per week eat mushrooms Week 2 Top of page

Primary: Diet_Times per week eat mushrooms Week 3 Top of page
End point title	Diet_Times per week eat mushrooms Week 3 [218]
End point description	None
End point type	Primary
End point timeframe	Week 3
Notes [218] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: Times Per Week 9 9 10
No statistical analyses for this end point

Primary: Diet_Times per week eat mushrooms Week 3 Top of page

Primary: Diet_Times per week eat mushrooms Week 3 Top of page
End point title	Diet_Times per week eat mushrooms Week 3 [219]
End point description	Once
End point type	Primary
End point timeframe	Week 3
Notes [219] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: Times Per Week 0 0 0
No statistical analyses for this end point

Primary: Diet_Times per week eat mushrooms Week 3 Top of page

Primary: Diet_Times per week eat mushrooms Week 3 Top of page
End point title	Diet_Times per week eat mushrooms Week 3 [220]
End point description	Twice
End point type	Primary
End point timeframe	Week 3
Notes [220] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: Times Per Week 0 0 0
No statistical analyses for this end point

Primary: Diet_Times per week eat mushrooms Week 3 Top of page

Primary: Diet_Times per week eat mushrooms Week 3 Top of page
End point title	Diet_Times per week eat mushrooms Week 3 [221]
End point description	Three or more
End point type	Primary
End point timeframe	Week 3
Notes [221] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: Times Per Week 0 1 0
No statistical analyses for this end point

Primary: Diet_Times per week eat mushrooms Week 3 Top of page

Primary: Diet_Times per week eat mushrooms Week 4 Top of page
End point title	Diet_Times per week eat mushrooms Week 4 [222]
End point description	None
End point type	Primary
End point timeframe	Week 4
Notes [222] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 9 9 Units: Times Per Week 10 8 8
No statistical analyses for this end point

Primary: Diet_Times per week eat mushrooms Week 4 Top of page

Primary: Diet_Times per week eat mushrooms Week 4 Top of page
End point title	Diet_Times per week eat mushrooms Week 4 [223]
End point description	Once
End point type	Primary
End point timeframe	Week 4
Notes [223] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 9 9 Units: Times Per Week 0 0 1
No statistical analyses for this end point

Primary: Diet_Times per week eat mushrooms Week 4 Top of page

Primary: Diet_Times per week eat mushrooms Week 4 Top of page
End point title	Diet_Times per week eat mushrooms Week 4 [224]
End point description	Twice
End point type	Primary
End point timeframe	Week 4
Notes [224] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 9 9 Units: Times Per Week 0 0 0
No statistical analyses for this end point

Primary: Diet_Times per week eat mushrooms Week 4 Top of page

Primary: Diet_Times per week eat mushrooms Week 4 Top of page
End point title	Diet_Times per week eat mushrooms Week 4 [225]
End point description	Three or more
End point type	Primary
End point timeframe	Week 4
Notes [225] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 9 9 Units: Times Per Week 0 1 0
No statistical analyses for this end point

Primary: Diet_Times per week eat mushrooms Week 4 Top of page

Primary: Toxicity_Loss of Appetite Baseline Top of page
End point title	Toxicity_Loss of Appetite Baseline [226]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [226] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 1 1 0
No statistical analyses for this end point

Primary: Toxicity_Loss of Appetite Baseline Top of page

Primary: Toxicity_Loss of Appetite Week 1 Top of page
End point title	Toxicity_Loss of Appetite Week 1 [227]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [227] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 1 1 0
No statistical analyses for this end point

Primary: Toxicity_Loss of Appetite Week 1 Top of page

Primary: Toxicity_Loss of Appetite Week 2 Top of page
End point title	Toxicity_Loss of Appetite Week 2 [228]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [228] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 1 1 0
No statistical analyses for this end point

Primary: Toxicity_Loss of Appetite Week 2 Top of page

Primary: Toxicity_Loss of Appetite Week 3 Top of page
End point title	Toxicity_Loss of Appetite Week 3 [229]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [229] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: Patients 2 1 0
No statistical analyses for this end point

Primary: Toxicity_Loss of Appetite Week 3 Top of page

Primary: Toxicity_Loss of Appetite Week 4 Top of page
End point title	Toxicity_Loss of Appetite Week 4 [230]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [230] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 1 0 0
No statistical analyses for this end point

Primary: Toxicity_Loss of Appetite Week 4 Top of page

Primary: Toxicity_Nausea Baseline Top of page
End point title	Toxicity_Nausea Baseline [231]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [231] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 0 1 0
No statistical analyses for this end point

Primary: Toxicity_Nausea Baseline Top of page

Primary: Toxicity_Nausea Week 1 Top of page
End point title	Toxicity_Nausea Week 1 [232]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [232] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 3 2 0
No statistical analyses for this end point

Primary: Toxicity_Nausea Week 1 Top of page

Primary: Toxicity_Nausea Week 2 Top of page
End point title	Toxicity_Nausea Week 2 [233]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [233] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 9 Units: Patients 1 1 0
No statistical analyses for this end point

Primary: Toxicity_Nausea Week 2 Top of page

Primary: Toxicity_Nausea Week 3 Top of page
End point title	Toxicity_Nausea Week 3 [234]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [234] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: Patients 1 1 0
No statistical analyses for this end point

Primary: Toxicity_Nausea Week 3 Top of page

Primary: Toxicity_Nausea Week 4 Top of page
End point title	Toxicity_Nausea Week 4 [235]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [235] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 0 1 0
No statistical analyses for this end point

Primary: Toxicity_Nausea Week 4 Top of page

Primary: Toxicity_Vomiting Baseline Top of page
End point title	Toxicity_Vomiting Baseline [236]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [236] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 0 0 0
No statistical analyses for this end point

Primary: Toxicity_Vomiting Baseline Top of page

Primary: Toxicity_Vomiting Week 1 Top of page
End point title	Toxicity_Vomiting Week 1 [237]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [237] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 1 0 0
No statistical analyses for this end point

Primary: Toxicity_Vomiting Week 1 Top of page

Primary: Toxicity_Vomiting Week 2 Top of page
End point title	Toxicity_Vomiting Week 2 [238]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [238] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 0 0 0
No statistical analyses for this end point

Primary: Toxicity_Vomiting Week 2 Top of page

Primary: Toxicity_Vomiting Week 3 Top of page
End point title	Toxicity_Vomiting Week 3 [239]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [239] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: Patients 1 0 0
No statistical analyses for this end point

Primary: Toxicity_Vomiting Week 3 Top of page

Primary: Toxicity_Vomiting Week 4 Top of page
End point title	Toxicity_Vomiting Week 4 [240]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [240] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 0 0 0
No statistical analyses for this end point

Primary: Toxicity_Vomiting Week 4 Top of page

Primary: Toxicity_Diarrhoea Baseline Top of page
End point title	Toxicity_Diarrhoea Baseline [241]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [241] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 2 0 0
No statistical analyses for this end point

Primary: Toxicity_Diarrhoea Baseline Top of page

Primary: Toxicity_Diarrhoea Week 1 Top of page
End point title	Toxicity_Diarrhoea Week 1 [242]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [242] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 9 Units: Patients 4 2 3
No statistical analyses for this end point

Primary: Toxicity_Diarrhoea Week 1 Top of page

Primary: Toxicity_Diarrhoea Week 2 Top of page
End point title	Toxicity_Diarrhoea Week 2 [243]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [243] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 1 0 0
No statistical analyses for this end point

Primary: Toxicity_Diarrhoea Week 2 Top of page

Primary: Toxicity_Diarrhoea Week 3 Top of page
End point title	Toxicity_Diarrhoea Week 3 [244]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [244] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: Patients 1 0 0
No statistical analyses for this end point

Primary: Toxicity_Diarrhoea Week 3 Top of page

Primary: Toxicity_Diarrhoea Week 4 Top of page
End point title	Toxicity_Diarrhoea Week 4 [245]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [245] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 2 0 0
No statistical analyses for this end point

Primary: Toxicity_Diarrhoea Week 4 Top of page

Primary: Toxicity_Loss of weight Baseline Top of page
End point title	Toxicity_Loss of weight Baseline [246]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [246] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 1 1 0
No statistical analyses for this end point

Primary: Toxicity_Loss of weight Baseline Top of page

Primary: Toxicity_Loss of weight Week 1 Top of page
End point title	Toxicity_Loss of weight Week 1 [247]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [247] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 1 0 0
No statistical analyses for this end point

Primary: Toxicity_Loss of weight Week 1 Top of page

Primary: Toxicity_Loss of weight Week 2 Top of page
End point title	Toxicity_Loss of weight Week 2 [248]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [248] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 1 0 0
No statistical analyses for this end point

Primary: Toxicity_Loss of weight Week 2 Top of page

Primary: Toxicity_Loss of weight Week 3 Top of page
End point title	Toxicity_Loss of weight Week 3 [249]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [249] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: Patients 1 0 0
No statistical analyses for this end point

Primary: Toxicity_Loss of weight Week 3 Top of page

Primary: Toxicity_Loss of weight Week 4 Top of page
End point title	Toxicity_Loss of weight Week 4 [250]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [250] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 1 0 0
No statistical analyses for this end point

Primary: Toxicity_Loss of weight Week 4 Top of page

Primary: Toxicity_Headache Baseline Top of page
End point title	Toxicity_Headache Baseline [251]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [251] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 4 0 0
No statistical analyses for this end point

Primary: Toxicity_Headache Baseline Top of page

Primary: Toxicity_Headache Week 1 Top of page
End point title	Toxicity_Headache Week 1 [252]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [252] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 4 0 2
No statistical analyses for this end point

Primary: Toxicity_Headache Week 1 Top of page

Primary: Toxicity_Headache Week 2 Top of page
End point title	Toxicity_Headache Week 2 [253]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [253] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 2 0 0
No statistical analyses for this end point

Primary: Toxicity_Headache Week 2 Top of page

Primary: Toxicity_Headache Week 3 Top of page
End point title	Toxicity_Headache Week 3 [254]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [254] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: Patients 1 0 0
No statistical analyses for this end point

Primary: Toxicity_Headache Week 3 Top of page

Primary: Toxicity_Headache Week 4 Top of page
End point title	Toxicity_Headache Week 4 [255]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [255] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 2 0 1
No statistical analyses for this end point

Primary: Toxicity_Headache Week 4 Top of page

Primary: Toxicity_Rise at night to pass urine Baseline Top of page
End point title	Toxicity_Rise at night to pass urine Baseline [256]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [256] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 4 3 4
No statistical analyses for this end point

Primary: Toxicity_Rise at night to pass urine Baseline Top of page

Primary: Toxicity_Rise at night to pass urine Week 1 Top of page
End point title	Toxicity_Rise at night to pass urine Week 1 [257]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [257] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 1 2 3
No statistical analyses for this end point

Primary: Toxicity_Rise at night to pass urine Week 1 Top of page

Primary: Toxicity_Rise at night to pass urine Week 2 Top of page
End point title	Toxicity_Rise at night to pass urine Week 2 [258]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [258] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 2 2 3
No statistical analyses for this end point

Primary: Toxicity_Rise at night to pass urine Week 2 Top of page

Primary: Toxicity_Rise at night to pass urine Week 3 Top of page
End point title	Toxicity_Rise at night to pass urine Week 3 [259]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [259] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: Patients 2 2 3
No statistical analyses for this end point

Primary: Toxicity_Rise at night to pass urine Week 3 Top of page

Primary: Toxicity_Rise at night to pass urine Week 4 Top of page
End point title	Toxicity_Rise at night to pass urine Week 4 [260]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [260] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 9 Units: Patients 1 1 3
No statistical analyses for this end point

Primary: Toxicity_Rise at night to pass urine Week 4 Top of page

Primary: Toxicity_Thirst Baseline Top of page
End point title	Toxicity_Thirst Baseline [261]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [261] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 2 0 0
No statistical analyses for this end point

Primary: Toxicity_Thirst Baseline Top of page

Primary: Toxicity_Thirst Week 1 Top of page
End point title	Toxicity_Thirst Week 1 [262]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [262] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 2 0 0
No statistical analyses for this end point

Primary: Toxicity_Thirst Week 1 Top of page

Primary: Toxicity_Thirst Week 2 Top of page
End point title	Toxicity_Thirst Week 2 [263]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [263] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 3 0 0
No statistical analyses for this end point

Primary: Toxicity_Thirst Week 2 Top of page

Primary: Toxicity_Thirst Week 2 Top of page
End point title	Toxicity_Thirst Week 2 [264]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [264] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 3 0 0
No statistical analyses for this end point

Primary: Toxicity_Thirst Week 2 Top of page

Primary: Toxicity_Thirst Week 3 Top of page
End point title	Toxicity_Thirst Week 3 [265]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [265] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: Patients 2 0 0
No statistical analyses for this end point

Primary: Toxicity_Thirst Week 3 Top of page

Primary: Toxicity_Thirst Week 4 Top of page
End point title	Toxicity_Thirst Week 4 [266]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [266] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 3 0 1
No statistical analyses for this end point

Primary: Toxicity_Thirst Week 4 Top of page

Primary: Toxicity_Dizziness Baseline Top of page
End point title	Toxicity_Dizziness Baseline [267]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [267] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 0 0 1
No statistical analyses for this end point

Primary: Toxicity_Dizziness Baseline Top of page

Primary: Toxicity_Dizziness Week 1 Top of page
End point title	Toxicity_Dizziness Week 1 [268]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [268] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 1 0 1
No statistical analyses for this end point

Primary: Toxicity_Dizziness Week 1 Top of page

Primary: Toxicity_Dizziness Week 2 Top of page
End point title	Toxicity_Dizziness Week 2 [269]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [269] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 0 0 2
No statistical analyses for this end point

Primary: Toxicity_Dizziness Week 2 Top of page

Primary: Toxicity_Dizziness Week 3 Top of page
End point title	Toxicity_Dizziness Week 3 [270]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [270] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: Patients 1 0 1
No statistical analyses for this end point

Primary: Toxicity_Dizziness Week 3 Top of page

Primary: Toxicity_Dizziness Week 4 Top of page
End point title	Toxicity_Dizziness Week 4 [271]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [271] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 1 0 1
No statistical analyses for this end point

Primary: Toxicity_Dizziness Week 4 Top of page

Primary: Toxicity_Constipation Baseline Top of page
End point title	Toxicity_Constipation Baseline [272]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [272] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 1 0 1
No statistical analyses for this end point

Primary: Toxicity_Constipation Baseline Top of page

Primary: Toxicity_Constipation Week 1 Top of page
End point title	Toxicity_Constipation Week 1 [273]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [273] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 0 2 2
No statistical analyses for this end point

Primary: Toxicity_Constipation Week 1 Top of page

Primary: Toxicity_Constipation Week 2 Top of page
End point title	Toxicity_Constipation Week 2 [274]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [274] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 0 0 1
No statistical analyses for this end point

Primary: Toxicity_Constipation Week 2 Top of page

Primary: Toxicity_Constipation Week 3 Top of page
End point title	Toxicity_Constipation Week 3 [275]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [275] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: Patients 0 0 1
No statistical analyses for this end point

Primary: Toxicity_Constipation Week 3 Top of page

Primary: Toxicity_Constipation Week 4 Top of page
End point title	Toxicity_Constipation Week 4 [276]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [276] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 1 1 1
No statistical analyses for this end point

Primary: Toxicity_Constipation Week 4 Top of page

Primary: Toxicity_Fatigue Baseline Top of page
End point title	Toxicity_Fatigue Baseline [277]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [277] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 4 3 1
No statistical analyses for this end point

Primary: Toxicity_Fatigue Baseline Top of page

Primary: Toxicity_Fatigue Week 1 Top of page
End point title	Toxicity_Fatigue Week 1 [278]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [278] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 1 2 1
No statistical analyses for this end point

Primary: Toxicity_Fatigue Week 1 Top of page

Primary: Toxicity_Fatigue Week 2 Top of page
End point title	Toxicity_Fatigue Week 2 [279]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [279] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 3 1 2
No statistical analyses for this end point

Primary: Toxicity_Fatigue Week 2 Top of page

Primary: Toxicity_Fatigue Week 3 Top of page
End point title	Toxicity_Fatigue Week 3 [280]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [280] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: Patients 4 1 1
No statistical analyses for this end point

Primary: Toxicity_Fatigue Week 3 Top of page

Primary: Toxicity_Fatigue Week 4 Top of page
End point title	Toxicity_Fatigue Week 4 [281]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [281] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 5 0 1
No statistical analyses for this end point

Primary: Toxicity_Fatigue Week 4 Top of page

Primary: Toxicity_Bone Pain Baseline Top of page
End point title	Toxicity_Bone Pain Baseline [282]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [282] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 3 0 0
No statistical analyses for this end point

Primary: Toxicity_Bone Pain Baseline Top of page

Primary: Toxicity_Bone Pain Week 1 Top of page
End point title	Toxicity_Bone Pain Week 1 [283]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [283] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 9 Units: Patients 1 0 0
No statistical analyses for this end point

Primary: Toxicity_Bone Pain Week 1 Top of page

Primary: Toxicity_Bone Pain Week 2 Top of page
End point title	Toxicity_Bone Pain Week 2 [284]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [284] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 1 0 0
No statistical analyses for this end point

Primary: Toxicity_Bone Pain Week 2 Top of page

Primary: Toxicity_Bone Pain Week 3 Top of page
End point title	Toxicity_Bone Pain Week 3 [285]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [285] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: Patients 1 0 0
No statistical analyses for this end point

Primary: Toxicity_Bone Pain Week 3 Top of page

Primary: Toxicity_Bone Pain Week 4 Top of page
End point title	Toxicity_Bone Pain Week 4 [286]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [286] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 1 0 1
No statistical analyses for this end point

Primary: Toxicity_Bone Pain Week 4 Top of page

Primary: Toxicity_Muscle Weakness Baseline Top of page
End point title	Toxicity_Muscle Weakness Baseline [287]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [287] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 3 0 0
No statistical analyses for this end point

Primary: Toxicity_Muscle Weakness Baseline Top of page

Primary: Toxicity_Muscle Weakness Week 1 Top of page
End point title	Toxicity_Muscle Weakness Week 1 [288]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [288] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 1 0 0
No statistical analyses for this end point

Primary: Toxicity_Muscle Weakness Week 1 Top of page

Primary: Toxicity_Muscle Weakness Week 2 Top of page
End point title	Toxicity_Muscle Weakness Week 2 [289]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [289] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 3 0 0
No statistical analyses for this end point

Primary: Toxicity_Muscle Weakness Week 2 Top of page

Primary: Toxicity_Muscle Weakness Week 3 Top of page
End point title	Toxicity_Muscle Weakness Week 3 [290]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [290] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: Patients 1 0 0
No statistical analyses for this end point

Primary: Toxicity_Muscle Weakness Week 3 Top of page

Primary: Toxicity_Muscle Weakness Week 4 Top of page
End point title	Toxicity_Muscle Weakness Week 4 [291]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [291] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 1 0 0
No statistical analyses for this end point

Primary: Toxicity_Muscle Weakness Week 4 Top of page

Primary: Toxicity_Abdominal Pain Baseline Top of page
End point title	Toxicity_Abdominal Pain Baseline [292]
End point description
End point type	Primary
End point timeframe	Baseline
Notes [292] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 2 1 0
No statistical analyses for this end point

Primary: Toxicity_Abdominal Pain Baseline Top of page

Primary: Toxicity_Abdominal Pain Week 1 Top of page
End point title	Toxicity_Abdominal Pain Week 1 [293]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [293] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 1 2 2
No statistical analyses for this end point

Primary: Toxicity_Abdominal Pain Week 1 Top of page

Primary: Toxicity_Abdominal Pain Week 2 Top of page
End point title	Toxicity_Abdominal Pain Week 2 [294]
End point description
End point type	Primary
End point timeframe	Week 2
Notes [294] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 2 1 0
No statistical analyses for this end point

Primary: Toxicity_Abdominal Pain Week 2 Top of page

Primary: Toxicity_Abdominal Pain Week 3 Top of page
End point title	Toxicity_Abdominal Pain Week 3 [295]
End point description
End point type	Primary
End point timeframe	Week 3
Notes [295] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 9 10 10 Units: Patients 2 0 0
No statistical analyses for this end point

Primary: Toxicity_Abdominal Pain Week 3 Top of page

Primary: Toxicity_Abdominal Pain Week 4 Top of page
End point title	Toxicity_Abdominal Pain Week 4 [296]
End point description
End point type	Primary
End point timeframe	Week 4
Notes [296] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 2 1 0
No statistical analyses for this end point

Primary: Toxicity_Abdominal Pain Week 4 Top of page

Primary: Falls_Has fallen in the last week Week 1 Top of page
End point title	Falls_Has fallen in the last week Week 1 [297]
End point description
End point type	Primary
End point timeframe	Week 1
Notes [297] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only.
End point values Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Number of subjects analysed 10 10 10 Units: Patients 0 0 0
No statistical analyses for this end point

Primary: Falls_Has fallen in the last week Week 1 Top of page

Adverse events Top of page
Adverse events information
Timeframe for reporting adverse events	Baseline, week 1, 2, 3 and 4
Adverse event reporting additional description	Patients were asked about adverse events at each study visit.
Assessment type	Systematic
Dictionary used for adverse event reporting
Dictionary name	NCI CTCAE
Dictionary version	4.03
Reporting groups
Reporting group title	Cholecalciferol 300,000 IU
Reporting group description	Participants receiving cholecalciferol 300,000 IU
Reporting group title	Placebo
Reporting group description	Participants receiving placebo
Reporting group title	Cholecalciferol 600,000 IU
Reporting group description	Participants receiving 600,000 IU Cholecalciferol
Serious adverse events Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Total subjects affected by serious adverse events      subjects affected / exposed 0 / 10 (0.00%) 0 / 10 (0.00%) 0 / 10 (0.00%)      number of deaths (all causes) 0 0 0      number of deaths resulting from adverse events 0 0 0
Frequency threshold for reporting non-serious adverse events: 1%
Non-serious adverse events Cholecalciferol 300,000 IU Placebo Cholecalciferol 600,000 IU Total subjects affected by non serious adverse events      subjects affected / exposed 6 / 10 (60.00%) 2 / 10 (20.00%) 6 / 10 (60.00%) Nervous system disorders Headache      subjects affected / exposed 5 / 10 (50.00%) 0 / 10 (0.00%) 2 / 10 (20.00%)      occurrences all number 5 0 2 Dizziness      subjects affected / exposed 1 / 10 (10.00%) 0 / 10 (0.00%) 0 / 10 (0.00%)      occurrences all number 2 0 0 General disorders and administration site conditions Thirst      subjects affected / exposed 1 / 10 (10.00%) 0 / 10 (0.00%) 0 / 10 (0.00%)      occurrences all number 1 0 0 Fatigue      subjects affected / exposed 1 / 10 (10.00%) 0 / 10 (0.00%) 0 / 10 (0.00%)      occurrences all number 1 0 0 Fall      subjects affected / exposed 1 / 10 (10.00%) 0 / 10 (0.00%) 0 / 10 (0.00%)      occurrences all number 1 0 0 Flu like symptoms      subjects affected / exposed 0 / 10 (0.00%) 0 / 10 (0.00%) 1 / 10 (10.00%)      occurrences all number 0 0 1 Gastrointestinal disorders Diarrhoea      subjects affected / exposed 3 / 10 (30.00%) 1 / 10 (10.00%) 5 / 10 (50.00%)      occurrences all number 3 1 5 Indigestion      subjects affected / exposed 1 / 10 (10.00%) 0 / 10 (0.00%) 0 / 10 (0.00%)      occurrences all number 1 0 0 Nausea      subjects affected / exposed 1 / 10 (10.00%) 1 / 10 (10.00%) 0 / 10 (0.00%)      occurrences all number 1 1 0 Abdominal pain      subjects affected / exposed 1 / 10 (10.00%) 1 / 10 (10.00%) 1 / 10 (10.00%)      occurrences all number 1 1 1 Weight loss      subjects affected / exposed 1 / 10 (10.00%) 0 / 10 (0.00%) 0 / 10 (0.00%)      occurrences all number 1 0 0 Constipation      subjects affected / exposed 1 / 10 (10.00%) 0 / 10 (0.00%) 0 / 10 (0.00%)      occurrences all number 1 0 0 Abdominal Cramps      subjects affected / exposed 0 / 10 (0.00%) 0 / 10 (0.00%) 1 / 10 (10.00%)      occurrences all number 0 0 1 Musculoskeletal and connective tissue disorders Arthralgia      subjects affected / exposed 0 / 10 (0.00%) 0 / 10 (0.00%) 1 / 10 (10.00%)      occurrences all number 0 0 1

Adverse events Top of page

More information Top of page
Substantial protocol amendments (globally)
Were there any global substantial amendments to the protocol? Yes
Date	Amendment
17 Sep 2013	Submission to Research Ethics Committee of Protocol Version 1.1 which was created to address the comments in the Clinical Trial notice of non-acceptance of the initial clinical trial request.
17 Jun 2016	Updated documents due to additional dose of cholecalciferol being assessed in Part A dose confirmation: Protocol V3.2 20.10.2015 (Approved version 4.1 12/02/16) Translation of German SmPC (Address change of Copromoter) June 2014 GP Letter Part A Final 2.0 13.05.15 GP Letter Part B Final 2.0 13.05.15 Patient Card PART A 600,000 IU Final 2.0 13.05.15 Patient Card PART B Final 2.0 13.05.15 Vit D PIS_ICF Part A Final V2.0 15.05.15 Vit D PIS_ICF Part B Additional Samples Final Vit D PIS_ICF Part B Final v2.0 15.05.2015 Victoria Pharmaceuticals Product Specification 28.04.2015 Vitamin D diet questionnaire Final 1.0 02.10.2013 Viamin D falls questionnaire Final 1.0 02.10.2013 Vitamin D toxicity questionnaire Final 1.0 02.10.2013 MIA IMP V14 22.06.15
06 Sep 2016	Protocol updated to version 4.1 to incorporate MHRA comments from notice of non-acceptance of previous substantial amendment.
18 Oct 2017	Updated protocol to version 4.2 to allow a review of gastrointestinal adverse events and tolerability following the administration of the 600,000 IU liquid formulation.
Interruptions (globally)
Were there any global interruptions to the trial? No
Limitations and caveats
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
Data analysis is descriptive statistics only. Results for the Part A dose confirmation only are presented. It was not possible to confirm a suitable dose of the current liquid formulation within the context of the current protocol.

More information Top of page