Treatment of Calcium Deficiency in Young Women

Osteoporosis Clinical Trial

Official title:

Treatment of Calcium Deficiency in Young Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000426
• Other study ID #: R01AR042155
• Secondary ID: R01AR042155NIAMS
• Status: Completed
• Phase: Phase 2
• First received: November 3, 1999
• Last updated: June 27, 2013
• Start date: January 1995
• Est. completion date: June 2000

Study information

• Verified date: June 2013
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 27 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Calcium supplement

Locations

Country	Name	City	State
United States	Creighton University	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
Creighton University	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Heaney RP. Phosphorus nutrition and the treatment of osteoporosis. Mayo Clin Proc. 2004 Jan;79(1):91-7. Review. — View Citation