Optimizing Vitamin D Status During Initial Military Training

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
United States Army Research Institute of Environmental Medicine
ClinicalTrials.gov Identifier:
NCT01617109
First received: June 1, 2012
Last updated: August 16, 2013
Last verified: August 2013

June 1, 2012
August 16, 2013
June 2012
May 2014   (final data collection date for primary outcome measure)
Serum PTH pg/ml [ Time Frame: Participants will be followed for the duration of basic combat training or basic military training, which are 7-9 weeks ] [ Designated as safety issue: No ]
Serum PTH pg/ml [ Time Frame: Participants will be followed for the duration of basic combat training, which is 9 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01617109 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Optimizing Vitamin D Status During Initial Military Training
Optimizing Vitamin D Status During Initial Military Training: A Randomized, Double-blind, Placebo-controlled Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Bone Health
  • Nutrition Status
  • 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
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
  • Experimental: Ca/Vit D
    Intervention: Dietary Supplement: Ca/Vit D
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1400
May 2014
May 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 42 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01617109
H12-09; 13-24HC
No
United States Army Research Institute of Environmental Medicine
United States Army Research Institute of Environmental Medicine
Not Provided
Principal Investigator: James P McClung, Ph.D. US Army Research Institute of Environmental Medicine
United States Army Research Institute of Environmental Medicine
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP