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Completed

NCT Number: NCT02375503

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

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.

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Key information

Age range

17 year–42 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fort Jackson

Columbia, South Carolina, 29207, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calcium/Vitamin D

Dietary Supplement

Daily, calcium and vitamin D fortified snack bar

Placebo

Dietary Supplement

Primary outcomes

  1. Bone Turnover Markers

    Time frame: 8-10 weeks

    Participants will have a pre- and post- BCT blood draw

Secondary outcomes

  1. Bone Microarchitecture

    Time frame: 8-10 weeks

    Participants will receive a bone scan pre- and post- BCT in order to determine changes in bone microarchitecture

Sponsors and collaborators

Lead sponsor

United States Army Research Institute of Environmental Medicine

Fed

Collaborators

  • United States Department of Defense

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 2, 2015
Registry last updated
May 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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