Vitamin D Supplementation in Conscripts
Fitness and Health Characteristics in Conscripts With Supplementation of Vitamin D
1 other identifier
interventional
63
1 country
1
Brief Summary
A longitudinal, triple-blinded, randomized, placebo-controlled trial, with a 7-month follow-up period is conducted between October 2016 to April 2017.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 25, 2017
CompletedFirst Submitted
Initial submission to the registry
April 21, 2020
CompletedFirst Posted
Study publicly available on registry
April 24, 2020
CompletedSeptember 17, 2021
September 1, 2021
7 months
April 21, 2020
September 12, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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.
0, 2, 5 and 7 months of recruitment
Other Outcomes (6)
serum parathyroid hormone
0, 2, 5 and 7 months of recruitment
serum calcium
0, 2, 5 and 7 months of recruitment
serum ionized calcium
0, 2, 5 and 7 months of recruitment
- +3 more other outcomes
Study Arms (2)
Intervention
ACTIVE COMPARATORReceived vitamin D3 capsules (1200 IU/30µg).
Control
PLACEBO COMPARATORReceived placebo (oil capsules).
Interventions
Eligibility Criteria
You may qualify if:
- participating in military service at the Estonian Defence Forces
- voluntarity to participate in the study
You may not qualify if:
- inability to continue military service for any reason, during the 7 month follow-up period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Leho Ripslead
- Estonian Defence Forcescollaborator
- University of Tartucollaborator
Study Sites (1)
Kuperjanov Infantry Battalion, Estonian Defence Forces
Võru, Võrumaa, 50400, Estonia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Helena Gapeyeva, MD, PhD
University of Tartu
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Computed randomization was used to divide conscripts into two groups; either the intervention group, who received vitamin D3 capsules (1200 IU/30µg) or the control group, who received placebo (oil capsules).
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Head of department
Study Record Dates
First Submitted
April 21, 2020
First Posted
April 24, 2020
Study Start
October 1, 2016
Primary Completion
April 20, 2017
Study Completion
April 25, 2017
Last Updated
September 17, 2021
Record last verified: 2021-09