Clinical Trial Results:
A phase IV, randomised, parallel study to compare a monthly administration of vitamin D3 (D-CURE®) to a daily administration of vitamin D3 (VISTA-D3®).
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Summary
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EudraCT number |
2016-003755-29 |
Trial protocol |
BE |
Global end of trial date |
13 Mar 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
10 Dec 2017
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First version publication date |
10 Dec 2017
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Other versions |
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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 |
D-CURE-IV-16-1
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
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WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
Laboratoires SMB S.A.
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Sponsor organisation address |
Rue de la Pastorale, 26-28, Brussels, Belgium, 1080
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Public contact |
DEPARTEMENT CLINIQUE, LABORATOIRES SMB S.A, Dpt_Clinique@smb.be
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Scientific contact |
DEPARTEMENT CLINIQUE, LABORATOIRES SMB S.A, Dpt_Clinique@smb.be
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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 |
03 Jul 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
13 Mar 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
13 Mar 2017
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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 |
To determine whether a cumulative dose of vitamin D3 produces the same effects on the serum concentration of 25-hydroxyvitamin D if it is given daily or monthly.
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Protection of trial subjects |
For this study, no particular measure was taken to protect the trial subjects. Both study treatments (D-CURE and VISTA-D3) were already marketed in Belgium and then were well known by the most of participating subjects.
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Background therapy |
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Evidence for comparator |
- | ||
Actual start date of recruitment |
08 Nov 2016
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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 |
Belgium: 60
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Worldwide total number of subjects |
60
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EEA total number of subjects |
60
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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) |
60
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
The study was conducted in one center in Belgium. The recruitement was adequate to meet the target of 60 subjects . After the screening visit, the subjects were randomized in one of the two groups of treatment. The study extended over one period of 75 days followed by a blood sampling 30 days after the last administration of vitamin D3. | |||||||||
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Pre-assignment
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Screening details |
- Obtain signed ICF - Obtain demo data - Perform a medical history & physical examination - Take vital signs - Review prior/concomitant médications - Perform laboratory évaluations and pregnancy test - Review inclusion/exclusion criteria - Schedule the randomisation visit | |||||||||
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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 | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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D-CURE | |||||||||
Arm description |
The subjects received 2 ampoules of D-CURE of 25.000 IU each 25 days during 75 days. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
D-CURE 1 ml ampoule containing 25.000 IU
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral solution
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Routes of administration |
Oral use
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Dosage and administration details |
Two ampoules of 25.000 IU were taken every 25 days during a total period of 75 days (total dose = 150.000 IU)
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Arm title
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VISTA-D3 | |||||||||
Arm description |
The subjects received 1 melting tablet per day of VISTA-D3 of 2000 IU during 75 days consecutively. | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
VISTA-D3 melting tablet containing 2000 IU
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
One tablet was to be taken each day during a total period of 75 days (total dose = 150.000 IU)
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Baseline characteristics reporting groups
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Reporting group title |
Overall Trial
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
D-CURE
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Reporting group description |
The subjects received 2 ampoules of D-CURE of 25.000 IU each 25 days during 75 days. | ||
Reporting group title |
VISTA-D3
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Reporting group description |
The subjects received 1 melting tablet per day of VISTA-D3 of 2000 IU during 75 days consecutively. | ||
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End point title |
Mean change in serum 25(OH)D3 levels from baseline to D75. | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Baseline (Day 1) and Day 75
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Statistical analysis title |
Mixed model | ||||||||||||
Statistical analysis description |
Change from Baseline to day 75 in 25(OH)D3 serum level was compared between groups by a mixed model with group, Baseline value and group*Baseline as fixed factor and subject as random factors.
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Comparison groups |
VISTA-D3 v D-CURE
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Number of subjects included in analysis |
60
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
The AEs were recorded during the entire study period.
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
20
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Reporting groups
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Reporting group title |
D-CURE
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Reporting group description |
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Reporting group title |
VISTA-D3
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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 | |||
