Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Columbia, South Carolina 29207


Purpose:

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.


Study summary:

Stress fractures may affect up to 2-5% of male and 8-21% of female Soldiers during training, resulting in attrition in up to 60% of affected personnel. A recent report indicates that supplemental calcium (2000mg) and vitamin D (800-1000IU) stabilizes PTH, increases tibia volumetric bone mineral density in male and female recruits undergoing Army BCT, and reduces stress fracture incidence by up to 20% in female Nacy recruits. Bone macroarchitecture has been measured in response to basic training however, the resolution of standard peripheral quantitative computed tomography (pQCT) is insufficient for assessment of microarchitectural changes, which may underlie the pathophysiology of stress fracture. With the use of HRpQCT this study will allow the investigators to evaluate microarchitectural changes within the bone tissue and assess the efficacy of a moderate daily dose of calcium and vitamin D to support bone health during BCT.


Criteria:

Inclusion Criteria: - Female or male US Army recruits beginning Army basic combat training at Fort Jackson, South Carolina Exclusion Criteria: - 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


NCT ID:

NCT02375503


Primary Contact:

Principal Investigator
Erin Gaffney-Stomberg, Ph.D., R.D.
U.S. Army Research Institute of Environmental Medicine


Backup Contact:

N/A


Location Contact:

Columbia, South Carolina 29207
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 23, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.