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Sponsored by: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
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Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
ClinicalTrials.gov Identifier: | NCT00000426 |
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 | Intervention | Phase |
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Osteoporosis |
Drug: Calcium supplement |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Treatment of Calcium Deficiency in Young Women |
Estimated Enrollment: | 150 |
Study Start Date: | January 1995 |
Estimated Study Completion Date: | June 2000 |
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.
Ages Eligible for Study: | 19 Years to 27 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | R01 AR42155, NIAMS-005 |
Study First Received: | November 3, 1999 |
Last Updated: | December 28, 2006 |
ClinicalTrials.gov Identifier: | NCT00000426 |
Health Authority: | United States: Federal Government |
Calcium deficiency Dietary calcium Dietary protein Osteoporosis |
Calcium supplement Bone density Bone mass Bone mass accumulation |
Calcium, Dietary Musculoskeletal Diseases Osteoporosis Bone Diseases, Metabolic Bone Diseases |
Physiological Effects of Drugs Bone Density Conservation Agents Pharmacologic Actions |