Clinical Trial Results:
A phase IV, randomised, cross-over study to estimate the influence of food on the 25-hydroxyvitamin D3 serum level after vitamin D3 (D-CURE®) supplementation.
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Summary
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EudraCT number |
2014-003779-48 |
Trial protocol |
BE |
Global end of trial date |
23 Mar 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
12 Feb 2016
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First version publication date |
12 Feb 2016
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Other versions |
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Summary report(s) |
Synopsis |
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-14-1
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
LABORATOIRES SMB
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Sponsor organisation address |
26-28, rue de la Pastorale, 1082, Brussels, Belgium,
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Public contact |
CLINICAL DEPARTMENT, LABORATOIRES SMB S.A, 32 24120993, clinique@smb.be
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Scientific contact |
CLINICAL DEPARTMENT, LABORATOIRES SMB S.A, 32 24120993, 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 |
23 Jun 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
23 Mar 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
23 Mar 2015
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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 administration of vitamin D3 (D-CURE®) with food will improve the absorption and increase serum levels of 25-hydroxyvitamin D3.
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Protection of trial subjects |
For this study, no specific measures were put in place to protect trial subjects. The study treatment D-CURE was a product marketed by the Laboratoires SMB since 1974 in Belgium and then was well known by most of the participating subjects.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
22 Oct 2014
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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: 88
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Worldwide total number of subjects |
88
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EEA total number of subjects |
88
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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) |
88
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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 subject recruitment was adequate to meet the target enrolment goal of 88 subjects in less than one month (22/10/2014 - 06/11/2014). After the screening visit, the subjects were randomized in one of the two sequences of treatment. The study extended over two periods of 60+-3 days. | |||||||||
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Pre-assignment
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Screening details |
-Obtain signed ICF -Obtain demographic data -Perform a medical history & physical examination -Take vital signs -Review prior/concomitant medications -Perform a 25(OH)-D serum concentration assessment and laboratory evaluations : haematology, chemistry, calcium, phosphate, TSH, blood pregnancy test -Review inclusion/exclusion criteria | |||||||||
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Period 1
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Period 1 title |
Cross over phase (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 |
No
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Arm title
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D-CURE with standardized high fat breakfast | |||||||||
Arm description |
The subjects received 2 ampoules of D-CURE of 25.000 IU (total = 50.000 IU) on the first day of the period with a standardized high fat breakfast and stayed at the study site during 4 hours after the drug administration. | |||||||||
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 D-CURE (total 50.000 IU) were taken at the beginning of each of the two study periods in either fasting condition or after a standardized high fat breakfast according to the randomization list.
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Arm title
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D-CURE in fasting condition | |||||||||
Arm description |
The subjects received 2 ampoules of D-CURE of 25.000 IU (total = 50.000 IU) on the first day of the period in fasting conditions and stayed at the study site during 4 hours after the drug administration. | |||||||||
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 D-CURE (total 50.000 IU) were taken at the beginning of each of the two study periods in either fasting condition or after a standardized high fat breakfast according to the randomization list.
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Baseline characteristics reporting groups
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Reporting group title |
Cross over phase
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Reporting group description |
After being screened, 88 subjects were randomized in this study and completed the study. No premature withdrawal of randomized subjects was observed in the study. The safety and the ITT analysis were then performed on 88 patients. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
D-CURE with standardized high fat breakfast
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Reporting group description |
The subjects received 2 ampoules of D-CURE of 25.000 IU (total = 50.000 IU) on the first day of the period with a standardized high fat breakfast and stayed at the study site during 4 hours after the drug administration. | ||
Reporting group title |
D-CURE in fasting condition
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Reporting group description |
The subjects received 2 ampoules of D-CURE of 25.000 IU (total = 50.000 IU) on the first day of the period in fasting conditions and stayed at the study site during 4 hours after the drug administration. | ||
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End point title |
Mean change in serum 25(OH)D3 levels from baseline to D14. | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
baseline and Day 14 of each period.
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Statistical analysis title |
Mixed model | ||||||||||||
Comparison groups |
D-CURE with standardized high fat breakfast v D-CURE in fasting condition
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Number of subjects included in analysis |
176
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.025 | ||||||||||||
Method |
t-test, 1-sided | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Confidence interval |
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97.5% | ||||||||||||
sides |
1-sided
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lower limit |
-0.2 | ||||||||||||
upper limit |
- | ||||||||||||
Variability estimate |
Standard error of the mean
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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 |
18
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Reporting groups
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Reporting group title |
D-CURE with standardized high fat breakfast
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Reporting group description |
The subjects received 2 ampoules of D-CURE of 25.000 IU (total = 50.000 IU) on the first day of the period with a standardized high fat breakfast and stayed at the study site during 4 hours after the drug administration. | |||||||||||||||||||||
Reporting group title |
D-CURE in fasting condition
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Reporting group description |
The subjects received 2 ampoules of D-CURE of 25.000 IU (total = 50.000 IU) on the first day of the period in fasting conditions and stayed at the study site during 4 hours after the drug administration. | |||||||||||||||||||||
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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 | |||
