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Treatment of Calcium Deficiency in Young Women
This study has been completed.
Study NCT00000426   Information provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First Received: November 3, 1999   Last Updated: December 28, 2006   History of Changes

November 3, 1999
December 28, 2006
January 1995
 
 
 
Complete list of historical versions of study NCT00000426 on ClinicalTrials.gov Archive Site
 
 
 
Treatment of Calcium Deficiency in Young Women
Treatment of Calcium Deficiency in Young Women

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.

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.

Phase II
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Osteoporosis
Drug: Calcium supplement
 
Heaney RP. Phosphorus nutrition and the treatment of osteoporosis. Mayo Clin Proc. 2004 Jan;79(1):91-7. Review.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
150
June 2000
 

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
Female
19 Years to 27 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000426
 
R01 AR42155, NIAMS-005
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
 
Principal Investigator: Robert P. Heaney, MD Creighton University
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
February 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP