Clinical trial NCT02636348: Evaluation of Calcium and Vitamin D Supplementation During Marine Corps Training
Official title: Evaluation of Calcium and Vitamin D Supplementation for Optimizing Bone Health During Marine Corps Recruit Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition Status
Bone Health
Keywords: Calcium
Vitamin D
Lead sponsor: United States Army Research Institute of Environmental Medicine
Sponsor class: FED
Collaborators: name: Uniformed Services University of the Health Sciences
First posted: 2015-12-21
Enrollment: 380
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum Bone Health Biomarkers (Composite)
timeFrame: Measures will be taken at the beginning and end of Initial Military Training (IMT) which is approximately 12 weeks
Secondary outcomes:
measure: Bone Strength Indices (Composite)
timeFrame: Measures will be taken at the beginning and end of Initial Military Training (IMT) which is approximately 12 weeks
Other outcomes:
Locations:
city: Parris Island
country: United States
facility: Marine Corps Recruit Depot Parris Island
state: South Carolina
Study officials:
affiliation: United States Army Research Institute of Environmental Medicine
name: Erin Gaffney-Stomberg, Ph.D., R.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.