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Optimizing Vitamin D Status During Initial Military Training

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ClinicalTrials.gov Identifier: NCT01617109
Recruitment Status : Active, not recruiting
First Posted : June 12, 2012
Last Update Posted : August 10, 2016
Sponsor:
Information provided by (Responsible Party):
United States Army Research Institute of Environmental Medicine

Brief 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.


Condition or disease Intervention/treatment
Bone Health Nutrition Status Dietary Supplement: Ca/Vit D Other: Placebo

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Optimizing Vitamin D Status During Initial Military Training: A Randomized, Double-blind, Placebo-controlled Trial
Study Start Date : June 2012
Primary Completion Date : January 2014
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo Other: Placebo
administered as 5 pills daily or as 2 snack bars
Experimental: Ca/Vit D Dietary Supplement: Ca/Vit D
800IU vitamin D3 and 2000mg elemental calcium (as calcium carbonate); administered as 5 pills daily or 2 snack bars



Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 42 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01617109


Locations
United States, Oklahoma
Fort Sill
Fort Sill, Oklahoma, United States, 73503
United States, Texas
Lackland Air Force Base
San Antonio, Texas, United States, 78236
Sponsors and Collaborators
United States Army Research Institute of Environmental Medicine
Investigators
Principal Investigator: James P McClung, Ph.D. US Army Research Institute of Environmental Medicine

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: United States Army Research Institute of Environmental Medicine
ClinicalTrials.gov Identifier: NCT01617109     History of Changes
Other Study ID Numbers: H12-09; 13-24HC
First Posted: June 12, 2012    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by United States Army Research Institute of Environmental Medicine:
Vitamin D
Calcium
Parathyroid hormone
Bone
Bone formation
Bone resorption
Micronutrients
Trace Elements

Additional relevant MeSH terms:
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents