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Trial NCT00000613

Resource URI: http://static.linkedct.org/resource/trials/NCT00000613
linkedct:brief_title CVD Risk and Health in Postmenopausal Phytoestrogen Users
linkedct:condition <http://static.linkedct.org/resource/condition/10439>
linkedct:condition <http://static.linkedct.org/resource/condition/1761>
linkedct:condition <http://static.linkedct.org/resource/condition/2312>
linkedct:condition <http://static.linkedct.org/resource/condition/3388>
linkedct:condition <http://static.linkedct.org/resource/condition/3728>
linkedct:condition <http://static.linkedct.org/resource/condition/5702>
linkedct:condition <http://static.linkedct.org/resource/condition/8489>
linkedct:condition <http://static.linkedct.org/resource/condition/9389>
linkedct:criteria Postmenopausal women, ages 45 to 74.
linkedct:description BACKGROUND: Estrogen replacement therapy is beneficial for heart disease risk factors as well as for bone density. However, a large proportion of postmenopausal women are not compliant with therapeutic regimens. Phytoestrogens are naturally occurring compounds found in plants and soy products that have estrogenic effects, and may represent an alternative treatment for the prevention of heart disease and osteoporosis in postmenopausal women. However, few intervention trials have examined the extent to which it is possible to improve heart disease risk factors, bone density, and quality of life in postmenopausal women through use of a dietary supplement of phytoestrogen. DESIGN NARRATIVE: Randomized, double-blind, placebo-controlled study. A total of 210 women were enrolled in the study to be followed for one to two years. The women were randomized to phytoestrogen treatment or to placebo. Data are collected at baseline visits, at one and three month follow-up telephone calls, and at 6, 12, and 24 month follow-up clinic visits. Measures of high density lipoprotein and other heart disease risk factors, hip and spine bone density, and depression, life satisfaction, and quality of well-being are obtained. Cross-sectional and longitudinal comparisons of treatment and placebo groups are performed before and after adjustment and stratification for potentially confounding covariates. The study was renewed in March 2002 to assess whether the women treated with phytoestrogens had lowered homocysteine, interleukin-6, C-reactive protein, E-selectin, and decreased obesity and fat mass over two years.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Female
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 74 Years
linkedct:eligibility_minimum_age 45 Years
linkedct:end_date December 2004
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000613
rdfs:label Trial NCT00000613
linkedct:lastchanged_date January 3, 2006
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000613
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 116
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/14567>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000613>
linkedct:phase Phase 2
linkedct:reference <http://static.linkedct.org/resource/reference/12703>
linkedct:reference <http://static.linkedct.org/resource/reference/19308>
linkedct:reference <http://static.linkedct.org/resource/reference/9741>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date April 1997
linkedct:study_design Prevention, Randomized, Double-Blind, Placebo Control
linkedct:study_type Interventional
linkedct:summary To determine the acceptability and benefits of use of a dietary supplement of the phytoestrogen, genistein, versus placebo on heart disease risk factors, bone density, and psychosocial outcomes in postmenopausal women.
rdf:type linkedct:trials
linkedct:verification_date December 2005