An interventional study of Calcium/Vitamin D and Placebo in Nutrition Status and Bone Health, sponsored by United States Army Research Institute of Environmental Medicine. Completed at 1 site in United States. Open to participants aged 17 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-28.
Sponsored by United States Army Research Institute of Environmental Medicine · Not applicable, Interventional, and Prevention
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.
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.
United States Army Research Institute of Environmental Medicine is the lead sponsor of 67 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dietary supplement consumed as 2 calcium and vitamin D fortified snack bars per day
Dietary Supplement: Calcium/Vitamin D
Dietary supplement consumed as several capsules per day
Dietary Supplement: Calcium/Vitamin D
Placebo consumed as 2 isocaloric, unfortified snack bars per day
Dietary Supplement: Placebo
Placebo consumed as several capsules per day
Dietary Supplement: Placebo
2000 mg calcium and 1000 IU vitamin D administered daily as 8 pills or 2 fortified snack bars.
Administered daily as 8 placebo pills or 2 unfortified snack bars.
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)
Time frame: Measures will be taken at the beginning and end of Initial Military Training (IMT) which is approximately 12 weeks
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)
Time frame: Measures will be taken at the beginning and end of Initial Military Training (IMT) which is approximately 12 weeks
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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United States Army Research Institute of Environmental Medicine