Evaluation of Calcium and Vitamin D Supplementation During Marine Corps Training (MCRD-PI)

October 27, 2016 updated by: United States Army Research Institute of Environmental Medicine

Evaluation of Calcium and Vitamin D Supplementation for Optimizing Bone Health During Marine Corps Recruit Training

The primary objective of this randomized, double-blind, placebo-controlled trial is to determine the efficacy and effectiveness of Ca and vitamin D supplementation provided daily throughout Marine Corps recruit training on maintenance of PTH and indices of bone strength in Marine Corps recruits. The investigators hypothesize that Ca+D will prevent elevations in PTH and result in greater increases in indices of bone strength compared to placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Military recruits undergoing initial military training (IMT) are 17 times more likely to develop stress fractures compared to active duty service members. Up to 800 male and female recruits will be enrolled at the MCRD, Parris Island, SC over two seasons (summer/fall and winter/spring) in order to account for seasonal variation in vitamin D status. Ca (2000 mg/d) and vitamin D (1000 IU/d) will be supplied as either capsules or a fortified food product daily throughout training. This study will provide novel data for the military, medical and scientific communities regarding the relationship between Ca and vitamin D supplementation and biomarkers of immune function, and the requirements for calcium and vitamin D to support bone health during IMT.

Study Type

Interventional

Enrollment (Actual)

380

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
    • South Carolina
      • Parris Island, South Carolina, United States, 29905
        • Marine Corps Recruit Depot Parris Island

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 and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female Marine Corps recruit at least 17 years of age.

Exclusion Criteria:

  • Pregnant or breastfeeding
  • History of kidney stones or kidney disease
  • History of endocrine disorders
  • Allergies to any component of the food product bar

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
Experimental: Calcium/Vitamin D Bar
Dietary supplement consumed as 2 calcium and vitamin D fortified snack bars per day
Dietary supplement: Calcium/Vitamin D
2000 mg calcium and 1000 IU vitamin D administered daily as 8 pills or 2 fortified snack bars.
Experimental: Calcium/Vitamin D Pill
Dietary supplement consumed as several capsules per day
Dietary supplement: Calcium/Vitamin D
2000 mg calcium and 1000 IU vitamin D administered daily as 8 pills or 2 fortified snack bars.
Placebo Comparator: Placebo Bar
Placebo consumed as 2 isocaloric, unfortified snack bars per day
Dietary supplement: Placebo
Administered daily as 8 placebo pills or 2 unfortified snack bars.
Placebo Comparator: Placebo Pill
Placebo consumed as several capsules per day
Dietary supplement: Placebo
Administered daily as 8 placebo pills or 2 unfortified snack bars.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Bone Health Biomarkers (Composite)
Time Frame: Measures will be taken at the beginning and end of Initial Military Training (IMT) which is approximately 12 weeks

Effect of calcium/vitamin D on the following serum biomarkers:

25(OH)D (ng/ml), parathyroid hormone (PTH) (pg/ml), C-telopeptide cross-links of type 1 collagen (CTX) (ng/ml), tartrate-resistant acid phosphatase (TRAP) (U/L), bone alkaline phosphatase (BAP) (ug/L), procollagen I N-terminal peptide (P1NP) (ug/L)
Measures will be taken at the beginning and end of Initial Military Training (IMT) which is approximately 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone Strength Indices (Composite)
Time Frame: Measures will be taken at the beginning and end of Initial Military Training (IMT) which is approximately 12 weeks

Effect of calcium/vitamin D on the following indices of bone strength as assessed by peripheral quantitative computed tomography (pQCT):

volumetric bone mineral density (vBMD) (mg/cm3), bone strength index (BSI) (mg/mm4), cortical bone mineral content (Crt BMC) (mg/mm), cortical volumetric bone mineral density (Crt vBMD) (mg/cm3), strength strain index (SSI) (no units)
Measures will be taken at the beginning and end of Initial Military Training (IMT) which is approximately 12 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

Collaborators

Uniformed Services University of the Health Sciences

Investigators

  • Principal Investigator: Erin Gaffney-Stomberg, Ph.D., R.D., United States 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

July 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

June 24, 2015

First Submitted That Met QC Criteria

December 16, 2015

First Posted (Estimate)

December 21, 2015

Study Record Updates

Last Update Posted (Estimate)

October 28, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-21-HC

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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