Efficacy of a Once Daily Calcium and Vitamin D Fortified Food Product to Improve Bone Microarchitecture

Dietary Modification Clinical Trial

Official title:

Efficacy of a Once Daily Calcium and Vitamin D Fortified Food Product to Improve Bone Microarchitecture in Response to Army Basic Combat Training

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02375503
• Other study ID #: 15-07-HC
• Status: Completed
• Phase: N/A
• First received: February 24, 2015
• Last updated: May 12, 2017
• Start date: April 2015
• Est. completion date: June 2015

Study information

• Verified date: May 2017
• Source: United States Army Research Institute of Environmental Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Alteration
• Dietary Modification

Intervention

Dietary Supplement:
• Calcium/Vitamin D
Daily, calcium and vitamin D fortified snack bar
• Placebo

Locations

Country	Name	City	State
United States	Fort Jackson	Columbia	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
United States Army Research Institute of Environmental Medicine	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Turnover Markers	Participants will have a pre- and post- BCT blood draw	8-10 weeks
Secondary	Bone Microarchitecture	Participants will receive a bone scan pre- and post- BCT in order to determine changes in bone microarchitecture	8-10 weeks