Treatment of Calcium Deficiency in Young Women

This study has been completed.

First Received on November 3, 1999. Last Updated on December 28, 2006 History of Changes

Sponsor:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:	NCT00000426

Purpose

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
Osteoporosis	Drug: Calcium supplement	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Treatment of Calcium Deficiency in Young Women

Resource links provided by NLM:

MedlinePlus related topics: Bone Density Calcium Dietary Supplements Osteoporosis

Drug Information available for: Calcium gluconate

U.S. FDA Resources

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Estimated Enrollment:	150
Study Start Date:	January 1995
Estimated Study Completion Date:	June 2000

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.

Eligibility

Ages Eligible for Study:	19 Years to 27 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000426

Locations

United States, Nebraska
Creighton University
Omaha, Nebraska, United States, 68131

Sponsors and Collaborators

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

Investigators

Principal Investigator:

Robert P. Heaney, MD

Creighton University

More Information

Publications:

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

ClinicalTrials.gov Identifier:	NCT00000426 History of Changes
Other Study ID Numbers:	R01 AR42155, NIAMS-005
Study First Received:	November 3, 1999
Last Updated:	December 28, 2006
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Calcium deficiency
Dietary calcium
Dietary protein
Osteoporosis

Calcium supplement
Bone density
Bone mass
Bone mass accumulation

Additional relevant MeSH terms:

Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012