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Treatment of Calcium Deficiency in Young Women

Phase 2
Completed
Conditions
Osteoporosis
Registration Number
NCT00000426
Lead Sponsor
Creighton University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
150
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Creighton University

🇺🇸

Omaha, Nebraska, United States

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