- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04359524
Vitamin D Supplementation in Conscripts
Fitness and Health Characteristics in Conscripts With Supplementation of Vitamin D
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Body mass (kg) and height (cm) is measured by the same person at the medical center using standardized equipment and the body mass index (BMI) is calculated in kg/m2.
Computed randomization is used to divide conscripts into two groups; either the intervention group or the control group. Both types of capsules are administered once per day in the morning before breakfast for 7 months. Standardized coded packages (3 per conscript) and capsules (100 per package) are manufactured on a special order by Innopharma A/S (Denmark). No commercial sponsoring is involved.
The key of the package code is stored in the computer database until unblinding of the results.
Laboratory measurements Serum samples for clinical chemistry analysis are collected into serum clot activator tubes. Calcium measurements are performed using spectrophotometry method. Ionized calcium measurements are performed using ion selective electrodes. The direct chemiluminescent immunoassay method is used for measurement of PTH. 25(OH)D is measured using direct chemiluminescent immunoassay method.
Power calculation The primary variable of the study is the level of 25 (OH)D in the serum. In the power analysis a difference of 20 nmol/L between the intervention and the control group is considered to be meaningful to detect. If the SD would be 25 nmol/L, then 26 participants would be needed in each group to reach a power of 80%.
Statistical analysis The distribution of blood serum values in the study groups is described by means and standard deviations (SD). Differences in mean values of the variables of interest between the groups are evaluated using Welch t-test. The within group comparisons over time are performed using paired t-test with Bonferroni correction. Distributions of categorical variables are described by absolute numbers and percentages and compared between groups using the Fisher exact test. Statistical significance is set at the 0.05 probability level.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Võrumaa
-
Võru, Võrumaa, Estonia, 50400
- Kuperjanov Infantry Battalion, Estonian Defence Forces
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- participating in military service at the Estonian Defence Forces
- voluntarity to participate in the study
Exclusion Criteria:
- inability to continue military service for any reason, during the 7 month follow-up period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Intervention
Received vitamin D3 capsules (1200 IU/30µg).
|
|
PLACEBO_COMPARATOR: Control
Received placebo (oil capsules).
|
Placebo oil capsule
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of vitamin D deficence
Time Frame: 0, 2, 5 and 7 months of recruitment
|
Prevalence of vitamin D deficence as measured serum vitamin D 25(OH)D concentration.
Vitamin D was considered as sufficient if the se-rum 25(OH)D concentration was ≥75 nmol/L, insufficient if <75 nmol/L, and deficient if <50 nmol/L.
|
0, 2, 5 and 7 months of recruitment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
serum parathyroid hormone
Time Frame: 0, 2, 5 and 7 months of recruitment
|
serum parathyroid hormone concentration (pmol/l)
|
0, 2, 5 and 7 months of recruitment
|
serum calcium
Time Frame: 0, 2, 5 and 7 months of recruitment
|
serum calcium (Ca) concentration (mmol/l)
|
0, 2, 5 and 7 months of recruitment
|
serum ionized calcium
Time Frame: 0, 2, 5 and 7 months of recruitment
|
serum ionized calcium (Ca-i) concentration (mmol/l)
|
0, 2, 5 and 7 months of recruitment
|
Hand Grip Strength
Time Frame: 0, 2, 5 and 7 months of recruitment
|
Hand grip strength is determined by isometric contraction while standing, upper limb away from the body, using a hand dynamometer (Lafayette Instrument Co., USA).
|
0, 2, 5 and 7 months of recruitment
|
Testosterone
Time Frame: 0, 2, 5 and 7 months of recruitment
|
Serum testosterone concentration (nmol/l)
|
0, 2, 5 and 7 months of recruitment
|
Cortisol
Time Frame: 0, 2, 5 and 7 months of recruitment
|
Serum cortisol concentration (nmol/l)
|
0, 2, 5 and 7 months of recruitment
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Helena Gapeyeva, MD, PhD, University of Tartu
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R-002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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