Optimizing Vitamin D Status During Initial Military Training

Study Overview
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Brief Summary
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The primary objective of this randomized, double-blind, placebo-controlled trial is to determine the effect of vitamin D and calcium supplementation (800IU and 2000mg, respectively) on biochemical indicators of nutritional status and bone health in military personnel during Army basic combat training (BCT) and Air Force basic military training (BMT). The investigators hypothesize that daily supplementation with vitamin D and calcium during military training will improve vitamin D status, stabilize PTH levels, and result in improvements in markers of bone health. As a result of the investigators study design, the findings will provide critically important data regarding the concentration of vitamin D in blood necessary to stabilize PTH levels and to optimize bone formation during initial military training.

Detailed Description
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Vitamin D is an essential nutrient for maintaining bone health. Previous work from our laboratory indicates that vitamin D status may decline in Soldiers during BCT, even during the summer months in the Southeastern United States. Stress fractures may affect up to 5% of male and 21% of female Soldiers during training, resulting in attrition in up to 60% of affected personnel, but a recent report indicates that vitamin D and calcium supplementation may attenuate stress fracture risk by up to 20% in female Navy recruits. However, biochemical measures of nutritional status and associated markers of bone health were not collected in that study, leaving questions regarding the vitamin D and calcium requirements for military personnel during periods of elevated bone turnover.

Official Title
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Optimizing Vitamin D Status During Initial Military Training: A Randomized, Double-blind, Placebo-controlled Trial

Conditions
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Bone Health, Nutrition Status

Intervention / Treatment
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* Dietary Supplement: Ca/Vit D
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female or male US Army or US Air Force Recruits Participating in Basic Combat Training or Basic Military Training, respectively Exclusion Criteria: Pregnant or breastfeeding History of kidney stones or kidney disease

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* administered as 5 pills daily or as 2 snack bars<br>|
| Experimental: Ca/Vit D<br> | Dietary Supplement: Ca/Vit D<br>* 800IU vitamin D3 and 2000mg elemental calcium (as calcium carbonate); administered as 5 pills daily or 2 snack bars<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum PTH pg/ml |  | Participants will be followed for the duration of basic combat training or basic military training, which are 7-9 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, Calcium, Parathyroid hormone, Bone, Bone formation, Bone resorption, Micronutrients, Trace Elements