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Completed

NCT Number: NCT02636348

Evaluation of Calcium and Vitamin D Supplementation During Marine Corps 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.

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Key information

Conditions

Nutrition Status Bone Health

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marine Corps Recruit Depot Parris Island

Parris Island, South Carolina, 29905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calcium/Vitamin D

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

United States Army Research Institute of Environmental Medicine

Fed

Collaborators

  • Uniformed Services University of the Health Sciences

Registry information

Official study title

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

Acronym: MCRD-PI

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 21, 2015
Registry last updated
Oct 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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