Optimizing Vitamin D Status During Initial Military Training

October 10, 2018 updated by: United States Army Research Institute of Environmental Medicine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

342

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Fort Sill, Oklahoma, United States, 73503
        • Fort Sill
    • Texas
      • San Antonio, Texas, United States, 78236
        • Lackland Air Force base

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 42 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Participants will be followed for the duration of basic combat training or basic military training, which are 7-9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United States Army Research Institute of Environmental Medicine

Investigators

  • Principal Investigator: James P McClung, Ph.D., US Army Research Institute of Environmental Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

May 2, 2018

Study Registration Dates

First Submitted

June 1, 2012

First Submitted That Met QC Criteria

June 8, 2012

First Posted (Estimate)

June 12, 2012

Study Record Updates

Last Update Posted (Actual)

October 11, 2018

Last Update Submitted That Met QC Criteria

October 10, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H12-09; 13-24HC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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