Treatment of Calcium Deficiency in Young Women

NCT ID: NCT00000426

Last Updated: 2013-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1995-01-31
• Study Completion Date: 2000-06-30

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.

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.

Conditions

Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Calcium supplement

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 27 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

Creighton University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert P. Heaney, MD

Role: PRINCIPAL_INVESTIGATOR

Creighton University

Locations

Creighton University

Omaha, Nebraska, United States

Countries

United States

References

Heaney RP. Phosphorus nutrition and the treatment of osteoporosis. Mayo Clin Proc. 2004 Jan;79(1):91-7. doi: 10.4065/79.1.91.

Reference Type: BACKGROUND

PMID: 14708952 (View on PubMed)

Other Identifiers

R01AR042155

Identifier Type: NIH

Identifier Source: secondary_id

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NIAMS-005

Identifier Type: -

Identifier Source: secondary_id

R01AR042155

Identifier Type: NIH

Identifier Source: org_study_id

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