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A Study of Changes in Bone Mineral Density as a Function of Consuming Two Different Forms of Calcium Carbonate

NCT01857154 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2013-11-25

No results posted yet for this study

Summary

The purpose of this study is to determine whether consuming calcium carbonate that has been micronized is more effective than the traditional form of calcium carbonate in maintaining or increasing bone mineral density in people who are currently taking bisphosphonates or other bone-health medications.

Conditions

  • Osteopenia, Osteoporosis

Interventions

DIETARY_SUPPLEMENT

Micronized Calcium Carbonate

Subjects currently being treated with bisphosphonates will be administered 500 mg micronized calcium carbonate. Subjects not currently being treated with bisphosphonates will be administered 500 mg micronized calcium carbonate.

DIETARY_SUPPLEMENT

Non-Micronized Calcium Carbonate

Subjects currently being treated with bisphosphonates will be administered 1000 mg non-micronized calcium carbonate. Subjects not currently being treated with bisphosphonates will be administered 1000 mg non- micronized calcium carbonate.

DIETARY_SUPPLEMENT

Vitamin D3

All subjects in the study cohort will be administered 800 IU Vitamin D3.

Sponsors & Collaborators

  • Integrative Health Technologies, Inc.

    lead NETWORK

Principal Investigators

  • Gilbert R Kaats, PhD FACN · Integrative Health Technologies, Inc.

  • Harry G Preuss, MD MACN · Georgetown University Medical Center, Dept of Biochemistry, Medicine and Pathology

  • Sidney J Stohs, PhD · Dean Emeritus, Creighton University Health Sciences Center

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-09-30
Completion
2014-10-31

Countries

  • United States

Study Locations

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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 NCT01857154 on ClinicalTrials.gov