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Treatment of Calcium Deficiency in Young Women

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Calcium supplement
Sponsored by
Creighton University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring Calcium deficiency, Dietary calcium, Dietary protein, Osteoporosis, Calcium supplement, Bone density, Bone mass, Bone mass accumulation

Eligibility Criteria

19 Years - 27 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Creighton University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
June 27, 2013
Sponsor
Creighton University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT00000426
Brief Title
Treatment of Calcium Deficiency in Young Women
Official Title
Treatment of Calcium Deficiency in Young Women
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
January 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2000 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Creighton University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Calcium deficiency, Dietary calcium, Dietary protein, Osteoporosis, Calcium supplement, Bone density, Bone mass, Bone mass accumulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
150 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Calcium supplement

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
27 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert P. Heaney, MD
Organizational Affiliation
Creighton University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Creighton University
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
14708952
Citation
Heaney RP. Phosphorus nutrition and the treatment of osteoporosis. Mayo Clin Proc. 2004 Jan;79(1):91-7. doi: 10.4065/79.1.91.
Results Reference
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Treatment of Calcium Deficiency in Young Women

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