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
Summary
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EudraCT number |
2012-005232-29 |
Trial protocol |
HU |
Global end of trial date |
11 Dec 2013
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Results information
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Results version number |
v1(current) |
This version publication date |
23 Oct 2021
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First version publication date |
23 Oct 2021
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Other versions |
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Summary report(s) |
Clinical Study Summary PAT12-730DS |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
PAT12-730DS
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Pharma Patent Kft.
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Sponsor organisation address |
Szentlászlói út 44., Szentendre, Hungary, 2000
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Public contact |
Iroda-törzskönyvezés, Pharma Patent Kft, +36 1630 6182, clinical@pharmapatent.hu
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Scientific contact |
Iroda-törzskönyvezés, Pharma Patent Kft, +36 1630 6182, clinical@pharmapatent.hu
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
14 Jan 2014
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
11 Dec 2013
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Was the trial ended prematurely? |
No
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General information about the trial
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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.
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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.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
28 Feb 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Hungary: 89
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Worldwide total number of subjects |
89
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EEA total number of subjects |
89
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
70
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From 65 to 84 years |
19
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||||||||||||||
Pre-assignment
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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
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Period 1 title |
overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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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
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
1000 IU once a day, per os
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Arm title
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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
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
7000 IU once a week, per os
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Arm title
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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
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
30000 IU once a month, per os
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Investigational medicinal product name |
30000 IU kolekalciferol
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
30000 IU once a week, per os
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Arm title
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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
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
30000 IU once a week, per os
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End points reporting groups
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Reporting group title |
Group "A"
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Reporting group description |
1000 IU kolekalciferol (Vitamin D3), 1000 IU once a day, per os | ||
Reporting group title |
Group "B"
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Reporting group description |
7000 IU kolekalciferol (Vitamin D3), 7000 IU once a week, per os | ||
Reporting group title |
Group "C"
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Reporting group description |
30000 IU kolekalciferol (Vitamin D3), 30000 IU once a month, per os | ||
Reporting group title |
Group "D"
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Reporting group description |
30000 IU kolekalciferol (Vitamin D3), 30000 IU once a week, per os |
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End point title |
Changes in 25(OH)D versus to baseline in each group | |||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
90 days
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Statistical analysis title |
ANOVA | |||||||||||||||
Statistical analysis description |
ANOVA and paired test of Dunnett.
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Comparison groups |
Group "B" v Group "C" v Group "D" v Group "A"
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Number of subjects included in analysis |
82
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Analysis specification |
Pre-specified
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Analysis type |
superiority [1] | |||||||||||||||
P-value |
≤ 0.05 | |||||||||||||||
Method |
ANOVA | |||||||||||||||
Parameter type |
Mean difference (final values) | |||||||||||||||
Point estimate |
28
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Confidence interval |
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level |
95% | |||||||||||||||
sides |
2-sided
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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% |
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Adverse events information
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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.
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||
Dictionary version |
15
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Reporting groups
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Reporting group title |
D group
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Reporting group description |
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Reporting group title |
A group
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Reporting group description |
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Reporting group title |
B group
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Reporting group description |
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Reporting group title |
C group
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Reporting group description |
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Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |