Vitamin D DeficiencyNCT04359524
Vitamin D Supplementation in Conscripts
A study testing Vitamin D3 (1200 IU/30µg) in people with Vitamin D Deficiency and Military Activity, run by Leho Rips at 1 site in Estonia.
Trial summary
A longitudinal, triple-blinded, randomized, placebo-controlled trial, with a 7-month follow-up period is conducted between October 2016 to April 2017. Read more about this study
- Who is it for?
- Ages 19 to 27 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Military Activity
- What is being tested?
- Vitamin D3 (1200 IU/30µg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteEstonia
- Study dates
- 1 Oct 2016to 25 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 27 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- participating in military service at the Estonian Defence Forces
- voluntarity to participate in the study
Who cannot join
- inability to continue military service for any reason, during the 7 month follow-up period
Trial locations and contacts
1 site in 1 country.
Estonia1 site
Kuperjanov Infantry Battalion, Estonian Defence Forces
Võru, Võrumaa, 50400
About this study
Official title: Fitness and Health Characteristics in Conscripts With Supplementation of Vitamin D
A longitudinal, triple-blinded, randomized, placebo-controlled trial, with a 7-month follow-up period is conducted between October 2016 to April 2017.
Read the 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.
- Conditions
- Vitamin D Deficiency, Military Activity
- Being tested
- Vitamin D3 (1200 IU/30µg), Placebo
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 (1200 IU/30µg)Dietary supplement
PlaceboDietary supplement
Placebo oil capsule
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Received vitamin D3 capsules (1200 IU/30µg). Receives: Dietary Supplement: Vitamin D3 (1200 IU/30µg) |
| Control | Placebo comparator | Received placebo (oil capsules). Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of vitamin D deficence
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.
Measured: 0, 2, 5 and 7 months of recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Oct 2016
- Primary completion20 Apr 2017
- Study completion25 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Triple blinded randomized placebo-controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leho Rips
- Sponsor type
- University, hospital or other
- Collaborators
- Estonian Defence Forces, University of Tartu
- Responsible party
- Sponsor-investigator, Leho Rips, Tartu University Hospital
- Investigators
- Helena Gapeyeva, MD, PhD, Study director, University of Tartu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359524
- Sponsor's protocol ID
- R-002
- Status last verified
- Sep 2021
- First submitted
- 21 Apr 2020
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fitness and Health Characteristics in Conscripts With Supplementation of Vitamin D
- ClinicalTrials.gov ID
- NCT04359524
- Acronym / sponsor ID
- R-002
- Conditions
- Vitamin D Deficiency, Military Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Leho RipsUniversity, hospital or other
- Collaborators
- Estonian Defence Forces, University of Tartu
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 20 Apr 2017 (actual)
- Study completion
- 25 Apr 2017 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A longitudinal, triple-blinded, randomized, placebo-controlled trial, with a 7-month follow-up period is conducted between October 2016 to April 2017.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Triple blinded randomized placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Dietary Supplement: Vitamin D3 (1200 IU/30µg)Received vitamin D3 capsules (1200 IU/30µg). |
| Control | Placebo comparator | Dietary Supplement: PlaceboReceived placebo (oil capsules). |
Who may qualify
- Ages
- 19 to 27 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- participating in military service at the Estonian Defence Forces
- voluntarity to participate in the study
Key exclusion criteria (1 listed)
- inability to continue military service for any reason, during the 7 month follow-up period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3 (1200 IU/30µg) | Dietary supplement | Intervention |
| PlaceboPlacebo oil capsule | Dietary supplement | Control |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helena Gapeyeva, MD, PhD study director
University of Tartu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 (1200 IU/30µg) in people with Vitamin D Deficiency and Military Activity, run by Leho Rips at 1 site in Estonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of vitamin D deficence (time frame: 0, 2, 5 and 7 months of recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2021.