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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
  Purpose

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 Intervention
Bone Health
Nutrition Status
Dietary Supplement: Ca/Vit D
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Optimizing Vitamin D Status During Initial Military Training: A Randomized, Double-blind, Placebo-controlled Trial

Resource links provided by NLM:


Further study details as provided by United States Army Research Institute of Environmental Medicine:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1400
Study Start Date: June 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 42 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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
  More Information

Publications:
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
Study First Received: June 1, 2012
Last Updated: August 16, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

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:
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014