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NCT02636348

Evaluation of Calcium and Vitamin D Supplementation During Marine Corps Training

NCT ID: NCT02636348

Last Updated: 2016-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Nutrition Status Bone Health

Keywords

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Calcium Vitamin D

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Calcium/Vitamin D Bar

Dietary supplement consumed as 2 calcium and vitamin D fortified snack bars per day

Group Type EXPERIMENTAL

Calcium/Vitamin D

Intervention Type DIETARY_SUPPLEMENT

2000 mg calcium and 1000 IU vitamin D administered daily as 8 pills or 2 fortified snack bars.

Calcium/Vitamin D Pill

Dietary supplement consumed as several capsules per day

Group Type EXPERIMENTAL

Calcium/Vitamin D

Intervention Type DIETARY_SUPPLEMENT

2000 mg calcium and 1000 IU vitamin D administered daily as 8 pills or 2 fortified snack bars.

Placebo Bar

Placebo consumed as 2 isocaloric, unfortified snack bars per day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Administered daily as 8 placebo pills or 2 unfortified snack bars.

Placebo Pill

Placebo consumed as several capsules per day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Administered daily as 8 placebo pills or 2 unfortified snack bars.

Interventions

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Calcium/Vitamin D

2000 mg calcium and 1000 IU vitamin D administered daily as 8 pills or 2 fortified snack bars.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Administered daily as 8 placebo pills or 2 unfortified snack bars.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Uniformed Services University of the Health Sciences

FED

Sponsor Role collaborator

United States Army Research Institute of Environmental Medicine

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Erin Gaffney-Stomberg, Ph.D., R.D.

Role: PRINCIPAL_INVESTIGATOR

United States Army Research Institute of Environmental Medicine

Locations

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Marine Corps Recruit Depot Parris Island

Parris Island, South Carolina, United States

Site Status

Countries

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United States

References

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Nakayama AT, Lutz LJ, Hruby A, Karl JP, McClung JP, Gaffney-Stomberg E. A dietary pattern rich in calcium, potassium, and protein is associated with tibia bone mineral content and strength in young adults entering initial military training. Am J Clin Nutr. 2019 Jan 1;109(1):186-196. doi: 10.1093/ajcn/nqy199.

Reference Type DERIVED

PMID: 30615068 (View on PubMed)

Other Identifiers

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15-21-HC

Identifier Type: -

Identifier Source: org_study_id