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Trial NCT00000402

Resource URI: http://static.linkedct.org/resource/trials/NCT00000402
PropertyValue
linkedct:brief_title Calcium and Bone Mass in Young Females
linkedct:condition <http://static.linkedct.org/resource/condition/9389>
linkedct:criteria Inclusion Criteria: - Pubertal stage II - Calcium intake below a threshold level - Caucasian - Normal health Exclusion Criteria: - Medications affecting calcium and bone metabolism - Chronic diseases - Metabolic bone disease - Abnormality in calcium metabolism
linkedct:description This study evaluates the effect of calcium on bone mass accretion over 7 years in a cohort of 354 young females who were in pubertal Stage II at the start of the study. The average age of study participants at entry was 11 years; at the end of the study participants were 18 years old. The study looks at skeletal development under the influence of heredity, nutrition (calcium), and physical exercise. We gave calcium to participants in one arm of this clinical trial calcium. Participants in the other arm of the trial were given a placebo. The main outcome variable is the bone mass measured at different skeletal regions. The study will also provide data about the efficacy of calcium supplementation with regard to hypertension prevention and obesity. The results of this research will be important in preventing osteoporosis.
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 13 Years
linkedct:eligibility_minimum_age 8 Years
linkedct:end_date December 2001
linkedct:enrollment 354 (xsd:int)
linkedct:firstreceived_date November 3, 1999
linkedct:id NCT00000402
rdfs:label Trial NCT00000402
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/181677>
linkedct:nct_id NCT00000402
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Long Term Effects of Calcium on Bone Mass in Young Females
linkedct:org_study_id R01 AR40736
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/60005>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000402>
linkedct:phase Phase 2
linkedct:reference <http://static.linkedct.org/resource/reference/25634>
linkedct:reference <http://static.linkedct.org/resource/reference/27168>
linkedct:reference <http://static.linkedct.org/resource/reference/27804>
linkedct:reference <http://static.linkedct.org/resource/reference/38571>
linkedct:reference <http://static.linkedct.org/resource/reference/45459>
linkedct:reference <http://static.linkedct.org/resource/reference/47537>
linkedct:reference <http://static.linkedct.org/resource/reference/48581>
linkedct:reference <http://static.linkedct.org/resource/reference/48964>
linkedct:reference <http://static.linkedct.org/resource/reference/51253>
linkedct:results_reference <http://static.linkedct.org/resource/results_reference/3651>
linkedct:secondary_id NIAMS-007
linkedct:source National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
linkedct:start_date August 1991
linkedct:study_design Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Bio-equivalence Study
linkedct:study_type Interventional
linkedct:summary We originally suggested that calcium in the diet is important in determining the amount of bone (bone mass) that builds up in young adults. We are testing the effect of calcium on bone mass in 354 Caucasian (white) girls. At the start of this 7-year study, the average age of the girls was 11 years, and they had not yet reached puberty. The study will also provide information about the effect of calcium on body composition (body fat) and blood pressure in young women. We have been giving calcium to one group of participants in this study and giving a placebo (an inactive pill, or "sugar pill") to the other group. The results of this research will be important in preventing osteoporosis, because building more bone as a young person should reduce a woman's chances of developing osteoporosis later in life.
rdf:type linkedct:trials
linkedct:verification_date February 2003