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Trial NCT00000426

Resource URI: http://static.linkedct.org/resource/trials/NCT00000426
linkedct:brief_title Treatment of Calcium Deficiency in Young Women
linkedct:condition <http://static.linkedct.org/resource/condition/9389>
linkedct: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
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Female
linkedct:eligibility_healthy_volunteers Accepts Healthy Volunteers
linkedct:eligibility_maximum_age 27 Years
linkedct:eligibility_minimum_age 19 Years
linkedct:end_date June 2000
linkedct:enrollment 150 (xsd:int)
linkedct:firstreceived_date November 3, 1999
linkedct:id NCT00000426
rdfs:label Trial NCT00000426
linkedct:lastchanged_date December 28, 2006
linkedct:lead_sponsor_agency National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
linkedct:location <http://static.linkedct.org/resource/location/196688>
linkedct:nct_id NCT00000426
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Treatment of Calcium Deficiency in Young Women
linkedct:org_study_id R01 AR42155
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/50952>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000426>
linkedct:phase Phase 2
linkedct:reference <http://static.linkedct.org/resource/reference/20571>
linkedct:secondary_id NIAMS-005
linkedct:source National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
linkedct:start_date January 1995
linkedct:study_design Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date February 2003