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Optimizing Vitamin D Status During Initial Military Training

This study is not yet open for participant recruitment.
Verified June 2012 by United States Army Research Institute of Environmental Medicine
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: June 8, 2012
Last verified: June 2012
History of Changes
  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 basic combat training (BCT).

The investigators hypothesize that daily supplementation with vitamin D and calcium during BCT 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 BCT and other military training programs.


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:

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

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, which is 9 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 700
Study Start Date: June 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Other: Placebo
administered as 5 pills daily
Experimental: Ca/Vit D Dietary Supplement: Ca/Vit D
800IU vitamin D3 and 2000mg elemental calcium (as calcium carbonate); administered as 5 pills daily

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 Recruit
  • Participating in Basic Combat Training

Exclusion Criteria:

  • Pregnant or breastfeeding
  • History of kidney stones or kidney disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01617109

Contacts
Contact: James P McClung, Ph.D. james.mcclung3@us.army.mil

Locations
United States, Oklahoma
Fort Sill Not yet recruiting
Fort Sill, Oklahoma, United States, 73503
Contact: James P McClung, Ph.D.     508-233-4979     james.mcclung3@us.army.mil    
Contact: Erin Gaffney-Stomberg, Ph.D., R.D.     508-233-59630     erin.g.stomberg.ctr@us.army.mil    
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
Study First Received: June 1, 2012
Last Updated: June 8, 2012
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:
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 16, 2013