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Treatment of Calcium Deficiency in Young Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000426
First Posted: November 4, 1999
Last Update Posted: June 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Creighton University
  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 2

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

Resource links provided by NLM:


Further study details as provided by Creighton University:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 27 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000426


Locations
United States, Nebraska
Creighton University
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Robert P. Heaney, MD Creighton University
  More Information

Publications:
Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT00000426     History of Changes
Other Study ID Numbers: R01AR042155 ( U.S. NIH Grant/Contract )
NIAMS-005
First Submitted: November 3, 1999
First Posted: November 4, 1999
Last Update Posted: June 28, 2013
Last Verified: June 2013

Keywords provided by Creighton University:
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
Metabolic Diseases
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs