Treatment of Calcium Deficiency in Young Women

Sponsor
Creighton University (Other)
Overall Status
Completed
CT.gov ID
NCT00000426
Collaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH)
150
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65
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Study Details

Study Description

Brief Summary

This study looks at the effects of calcium supplementation on bone density in women in their third decade of life. We placed women aged 19-27 who take in low amounts of calcium in their diets in one of two groups. We will give women in one group a placebo (inactive pill) and women in the other group 1500 milligrams of calcium per day (as calcium carbonate). We will monitor the results by looking at the change in bone mineral density measured at the hip, total body, forearm, and spine. Treatment will last 3 years.

Condition or Disease Intervention/Treatment Phase
  • Drug: Calcium supplement
Phase 2

Detailed Description

This is a randomized, controlled trial of calcium carbonate supplementation (1500 milligrams per day) in third-decade women with low calcium-to-protein intakes. We accept women aged 19-27 on the basis of good health and the 7-day food diary demonstrating a dietary calcium-to-protein ratio (in milligrams:grams) that does not exceed 13. The outcome variable is the change in BMD at hip, total body, forearm, and spine. Treatment lasts for 3 years. We expect that bone mass will increase in both groups but will increase to a greater extent in the calcium-supplemented group than in the nonsupplemented group.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
Treatment of Calcium Deficiency in Young Women
Study Start Date :
Jan 1, 1995
Study Completion Date :
Jun 1, 2000

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 27 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Women in good health

    • Dietary calcium-to-protein ratio (in mg:g, as assessed by 7-day food diary) does not exceed 13

    Exclusion Criteria:
    • Smoking

    • Pregnancy

    • Lactation

    • Endocrine disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Creighton University Omaha Nebraska United States 68131

    Sponsors and Collaborators

    • Creighton University
    • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    Investigators

    • Principal Investigator: Robert P. Heaney, MD, Creighton University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Creighton University
    ClinicalTrials.gov Identifier:
    NCT00000426
    Other Study ID Numbers:
    • R01AR042155
    • R01AR042155
    • NIAMS-005
    First Posted:
    Nov 4, 1999
    Last Update Posted:
    Jun 28, 2013
    Last Verified:
    Jun 1, 2013

    Study Results

    No Results Posted as of Jun 28, 2013