MedTrace Logo

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

NCT02375503 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2017-05-15

No results posted yet for this study

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.

Conditions

  • Bone Alteration
  • Dietary Modification

Interventions

DIETARY_SUPPLEMENT

Calcium/Vitamin D

Daily, calcium and vitamin D fortified snack bar

DIETARY_SUPPLEMENT

Placebo

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • United States Army Research Institute of Environmental Medicine

    lead FED

Principal Investigators

  • Erin Gaffney-Stomberg, Ph.D., R.D. · U.S. Army Research Institute of Environmental Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
17 Years
Max Age
42 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02375503 on ClinicalTrials.gov