Efficacy of a Once Daily Calcium and Vitamin D Fortified Food Product to Improve Bone Microarchitecture
Completed · Not applicable · Has a placebo group
Conditions studied: Bone Alteration, Dietary Modification
In brief
The primary objective of this randomized, double-blind, placebo controlled trial is to determine the efficacy of a once per day calcium (1000mg) and vitamin D (1000IU) fortified food product on bone turnover markers, including parathyroid hormone (PTH) and microarchitecture during Army basic military training (BCT). The investigators hypothesize that consumption of a once daily calcium and vitamin D fortified food product will stabilize PTH and contribute to improved bone microarchitecture compared to placebo. The results will determine the efficacy of daily supplementation with calcium and vitamin D on bone turnover markers as well as provide novel data regarding microarchitectural changes during BCT as assessed by high resolution peripheral computed tomography (HRpQCT) scanning.
Key facts
- Study ID
- NCT02375503
- Run by
- United States Army Research Institute of Environmental Medicine
- People needed
- 175
- Starts
- 2015-04-01
- Expected to finish
- 2015-06-01
- Last updated by the study team
- 2017-05-15
Who can join
Age: 17 and older, up to 42. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Female or male US Army recruits beginning Army basic combat training at Fort Jackson, South Carolina
You may not qualify if…
- Pregnant or breastfeeding
- History of kidney stones or kidney disease
- History of amenorrhea
- History or endocrine disorders
- History of bone modifying disorders
- Currently taking, or have taken glucocorticoid drugs in the 2 years prior to study participation
- Currently diagnosed as anemic by healthcare professional
- Those allergic to any component of the snack bar
Where it is running
- Fort Jackson — Columbia, South Carolina, United States
Full record on ClinicalTrials.gov
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