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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02375503

Enrollment

175

Registered

2015-03-02

Start date

2015-04-30

Completion date

2015-06-30

Last updated

2017-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Alteration, Dietary Modification

Keywords

Calcium, Vitamin D, Parathyroid Hormone, Bone, Microarchitecture

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.

Interventions

DIETARY_SUPPLEMENTCalcium/Vitamin D

Daily, calcium and vitamin D fortified snack bar

DIETARY_SUPPLEMENTPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

17 Years to 42 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Bone Turnover Markers	8-10 weeks	Participants will have a pre- and post- BCT blood draw

Secondary

Measure	Time frame	Description
Bone Microarchitecture	8-10 weeks	Participants will receive a bone scan pre- and post- BCT in order to determine changes in bone microarchitecture

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026