Optimizing Vitamin D Status During Initial Military Training

Bone Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01617109
• Other study ID #: H12-09; 13-24HC
• Status: Completed
• Phase: N/A
• Start date: June 2012
• Est. completion date: May 2, 2018

Study information

• Verified date: October 2018
• Source: United States Army Research Institute of Environmental Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 342
• Est. completion date: May 2, 2018
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Health
• Nutrition Status

Intervention

Dietary Supplement:
• Ca/Vit D
800IU vitamin D3 and 2000mg elemental calcium (as calcium carbonate); administered as 5 pills daily or 2 snack bars

Other:
• Placebo
administered as 5 pills daily or as 2 snack bars

Locations

Country	Name	City	State
United States	Fort Sill	Fort Sill	Oklahoma
United States	Lackland Air Force Base	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
United States Army Research Institute of Environmental Medicine

Country where clinical trial is conducted

United States, 

References & Publications (1)

Andersen NE, Karl JP, Cable SJ, Williams KW, Rood JC, Young AJ, Lieberman HR, McClung JP. Vitamin D status in female military personnel during combat training. J Int Soc Sports Nutr. 2010 Dec 14;7:38. doi: 10.1186/1550-2783-7-38. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum PTH pg/ml		Participants will be followed for the duration of basic combat training or basic military training, which are 7-9 weeks