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

United States Army Research Institute of Environmental Medicine

Status: Completed

Conditions: Bone Alteration; Dietary Modification

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Calcium/Vitamin D

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02375503

15-07-HC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 175 patients

Sex: All

Ages: 17 to 42 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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175 participants in 2 patient groups, including a placebo group

Calcium/Vitamin D

Experimental group

Description:

Dietary supplement distributed and consumed as one calcium and vitamin D fortified snack bar per day

Treatment:

Dietary Supplement: Calcium/Vitamin D

Placebo

Placebo Comparator group

Description:

Placebo distributed and consumed as one isocaloric, unfortified snack bar per day

Treatment:

Dietary Supplement: Placebo