Clinical Trial Results:
Controlled, randomized, four-arm comparative, open label, multi-centric trial to compare the efficacy and safety parameters of the once-a-week or once-a-month administered 7000 IU, or 30000 IU vitamin D (cholecalciferol) to a 1000 IU dosage applied daily in vitamin D deficient patients

Trial information Top of page
Trial identification
Sponsor protocol code	PAT12-730DS
Additional study identifiers
ISRCTN number	-
US NCT number	-
WHO universal trial number (UTN)	-
Sponsors
Sponsor organisation name	Pharma Patent Kft.
Sponsor organisation address	Szentlászlói út 44., Szentendre, Hungary, 2000
Public contact	Iroda-törzskönyvezés, Pharma Patent Kft, +36 1630 6182, clinical@pharmapatent.hu
Scientific contact	Iroda-törzskönyvezés, Pharma Patent Kft, +36 1630 6182, clinical@pharmapatent.hu
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	14 Jan 2014
Is this the analysis of the primary completion data?	No
Global end of trial reached?	Yes
Global end of trial date	11 Dec 2013
Was the trial ended prematurely?	No
General information about the trial
Main objective of the trial	Comparison efficacy by 25OHD and safety parameters of a daily single dose of 1000 IU to a once-a week or once-a month administered 7000 IU or 30000 IU vitamin D, respectively.
Protection of trial subjects	Specific measures were not needed. The only intervention during the course of study was blood sample collection. Patients were informed in details about the possible side effect and all the contacts of the medical support.
Background therapy	-
Evidence for comparator	-
Actual start date of recruitment	28 Feb 2013
Long term follow-up planned	No
Independent data monitoring committee (IDMC) involvement?	No
Population of trial subjects
Number of subjects enrolled per country
Country: Number of subjects enrolled	Hungary: 89
Worldwide total number of subjects	89
EEA total number of subjects	89
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)	70
From 65 to 84 years	19
85 years and over	0

Trial information Top of page

Subject disposition Top of page
Recruitment
Recruitment details	-
Pre-assignment
Screening details	D vitamin level <20ng/ml, Lab tests for 25(OH)D, seCa, PTH, Urine analysis, Lab blood test and routine chemistry. Screened 140 subjects, 89 enrolled. Main reason for exclusion: high D vitamine level.
Period 1
Period 1 title	overall trial (overall period)
Is this the baseline period?	Yes
Allocation method	Randomised - controlled
Blinding used	Not blinded
Arms
Are arms mutually exclusive	Yes
Arm title	Group "A"
Arm description	1000 IU kolekalciferol (Vitamin D3), 1000 IU once a day, per os
Arm type	Active comparator
Investigational medicinal product name	1000 IU kolekalciferol
Investigational medicinal product code
Other name
Pharmaceutical forms	Film-coated tablet
Routes of administration	Oral use
Dosage and administration details	1000 IU once a day, per os
Arm title	Group "B"
Arm description	7000 IU kolekalciferol (Vitamin D3), 7000 IU once a week, per os
Arm type	Active comparator
Investigational medicinal product name	7000 IU kolekalciferol
Investigational medicinal product code
Other name
Pharmaceutical forms	Film-coated tablet
Routes of administration	Oral use
Dosage and administration details	7000 IU once a week, per os
Arm title	Group "C"
Arm description	30000 IU kolekalciferol (Vitamin D3), 30000 IU once a month, per os
Arm type	Active comparator
Investigational medicinal product name	30000 IU kolekalciferol
Investigational medicinal product code
Other name
Pharmaceutical forms	Film-coated tablet
Routes of administration	Oral use
Dosage and administration details	30000 IU once a month, per os
Investigational medicinal product name	30000 IU kolekalciferol
Investigational medicinal product code
Other name
Pharmaceutical forms	Film-coated tablet
Routes of administration	Oral use
Dosage and administration details	30000 IU once a week, per os
Arm title	Group "D"
Arm description	30000 IU kolekalciferol (Vitamin D3), 30000 IU once a week, per os
Arm type	Active comparator
Investigational medicinal product name	30000 IU kolekalciferol
Investigational medicinal product code
Other name
Pharmaceutical forms	Film-coated tablet
Routes of administration	Oral use
Dosage and administration details	30000 IU once a week, per os
Number of subjects in period 1 Group "A" Group "B" Group "C" Group "D" Started 22 23 22 22 Completed 21 20 20 21 Not completed 1 3 2 1      Consent withdrawn by subject - 1 2 1      Lost to follow-up 1 2 - -

Subject disposition Top of page

Baseline characteristics Top of page

Baseline characteristics Top of page

End points Top of page
End points reporting groups
Reporting group title	Group "A"
Reporting group description	1000 IU kolekalciferol (Vitamin D3), 1000 IU once a day, per os
Reporting group title	Group "B"
Reporting group description	7000 IU kolekalciferol (Vitamin D3), 7000 IU once a week, per os
Reporting group title	Group "C"
Reporting group description	30000 IU kolekalciferol (Vitamin D3), 30000 IU once a month, per os
Reporting group title	Group "D"
Reporting group description	30000 IU kolekalciferol (Vitamin D3), 30000 IU once a week, per os

End points Top of page

Primary: Changes in 25(OH)D versus to baseline in each group Top of page
End point title	Changes in 25(OH)D versus to baseline in each group
End point description
End point type	Primary
End point timeframe	90 days
End point values Group "A" Group "B" Group "C" Group "D" Number of subjects analysed 21 20 20 21 Units: ng/ml 21 20 20 21
Statistical analysis title	ANOVA
Statistical analysis description	ANOVA and paired test of Dunnett.
Comparison groups	Group "B" v Group "C" v Group "D" v Group "A"
Number of subjects included in analysis	82
Analysis specification	Pre-specified
Analysis type	superiority [1]
P-value	≤ 0.05
Method	ANOVA
Parameter type	Mean difference (final values)
Point estimate	28
Confidence interval
level	95%
sides	2-sided
lower limit	27
upper limit	30
Notes [1] - 1. and 2. groups comparison level 81.5% 1. and 3. groups comparison level 80.6% 1. and 4. groups comparison level 99.5%

Primary: Changes in 25(OH)D versus to baseline in each group Top of page

Adverse events Top of page
Adverse events information
Timeframe for reporting adverse events	Recording of sign of adverse event were done by each visit and in between visit by the phone follow-up visits.
Assessment type	Systematic
Dictionary used for adverse event reporting
Dictionary name	MedDRA
Dictionary version	15
Reporting groups
Reporting group title	D group
Reporting group description	-
Reporting group title	A group
Reporting group description	-
Reporting group title	B group
Reporting group description	-
Reporting group title	C group
Reporting group description	-
Serious adverse events D group A group B group C group Total subjects affected by serious adverse events      subjects affected / exposed 0 / 22 (0.00%) 0 / 22 (0.00%) 0 / 23 (0.00%) 0 / 22 (0.00%)      number of deaths (all causes) 0 0 0 0      number of deaths resulting from adverse events
Frequency threshold for reporting non-serious adverse events: 5%
Non-serious adverse events D group A group B group C group Total subjects affected by non serious adverse events      subjects affected / exposed 2 / 22 (9.09%) 3 / 22 (13.64%) 5 / 23 (21.74%) 1 / 22 (4.55%) Endocrine disorders Laboratory disorder      subjects affected / exposed 2 / 22 (9.09%) 3 / 22 (13.64%) 5 / 23 (21.74%) 1 / 22 (4.55%)      occurrences all number 2 3 5 1

Adverse events Top of page

More information Top of page
Substantial protocol amendments (globally)
Were there any global substantial amendments to the protocol? No
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.
None reported

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