Evaluation of Calcium and Vitamin D Supplementation During Marine Corps Training

Bone Health Clinical Trial

— MCRD-PI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02636348
• Other study ID #: 15-21-HC
• Status: Completed
• Phase: N/A
• First received: June 24, 2015
• Last updated: October 27, 2016
• Start date: July 2015
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: United States Army Research Institute of Environmental Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: October 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 17 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bone Health
• Nutrition Status

Intervention

Dietary Supplement:
• Calcium/Vitamin D
2000 mg calcium and 1000 IU vitamin D administered daily as 8 pills or 2 fortified snack bars.
• Placebo
Administered daily as 8 placebo pills or 2 unfortified snack bars.

Locations

Country	Name	City	State
United States	Marine Corps Recruit Depot Parris Island	Parris Island	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
United States Army Research Institute of Environmental Medicine	Uniformed Services University of the Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Bone Health Biomarkers (Composite)	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	No
Secondary	Bone Strength Indices (Composite)	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	No