Clinical trial NCT02375503: Efficacy of a Once Daily Calcium and Vitamin D Fortified Food Product to Improve Bone Microarchitecture
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Alteration
Dietary Modification
Keywords: Calcium
Vitamin D
Parathyroid Hormone
Bone
Microarchitecture
Lead sponsor: United States Army Research Institute of Environmental Medicine
Sponsor class: FED
Collaborators: name: United States Department of Defense
First posted: 2015-03-02
Enrollment: 175
Sex: ALL
Minimum age (years): 17
Maximum age (years): 42
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Bone Turnover Markers
timeFrame: 8-10 weeks
Secondary outcomes:
measure: Bone Microarchitecture
timeFrame: 8-10 weeks
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Fort Jackson
state: South Carolina
Study officials:
affiliation: U.S. Army Research Institute of Environmental Medicine
name: Erin Gaffney-Stomberg, Ph.D., R.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lutz LJ, Gaffney-Stomberg E, Karl JP, Hughes JM, Guerriere KI, McClung JP. Dietary Intake in Relation to Military Dietary Reference Values During Army Basic Combat Training; a Multi-center, Cross-sectional Study. Mil Med. 2019 Mar 1;184(3-4):e223-e230. doi: 10.1093/milmed/usy153.