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Trial NCT00000600

Resource URI: http://static.linkedct.org/resource/trials/NCT00000600
linkedct:brief_title Vitamin E and C to Slow Progression of Common Carotid Artery Plaque Build-Up
linkedct:condition <http://static.linkedct.org/resource/condition/1288>
linkedct:condition <http://static.linkedct.org/resource/condition/13668>
linkedct:condition <http://static.linkedct.org/resource/condition/2312>
linkedct:condition <http://static.linkedct.org/resource/condition/2340>
linkedct:condition <http://static.linkedct.org/resource/condition/2475>
linkedct:condition <http://static.linkedct.org/resource/condition/5702>
linkedct:condition <http://static.linkedct.org/resource/condition/6778>
linkedct:criteria Inclusion Criteria: - African American
linkedct:description BACKGROUND: Evidence from epidemiologic studies, and from one unpublished study, suggests that greater intake of antioxidant vitamins is associated with reduced risk of coronary heart disease and stroke. Findings from an animal model indicate that increased intake of antioxidant vitamins prevents progression of aortic fatty streaks induced by an atherogenic diet, but not from more advanced injury-induced lesions. These observations suggest the hypothesis that increased antioxidant vitamin intake may prevent further progression of early atherosclerosis, possibly by means of reduced susceptibility of low density lipoprotein to oxidative modification and consequent cytotoxic, chemotactic, chemostatic, and unregulated uptake effects. A new, automated, low-cost, portable ultrasound system for determining intima-media thickness of the common carotid artery makes it feasible to test the primary prevention impact of antioxidant vitamins on early atherosclerosis. Results of two studies at the University of Southern California suggest that the low-density lipoprotein effects on common carotid artery intima-media thickness can be detected by automated methods within 12 to 24 months in small patient samples. Retardation of intima-media thickness progression was achieved in both studies without significant changes in average vessel diameter, which suggests effects on early atherosclerotic lesions. DESIGN NARRATIVE: Patients will be screened for carotid intima-media thickness at home or at schools in mobile vans equipped with portable ultrasound equipment. After 12 months, those patients above the age and sex-adjusted 66th percentile at Screen I will be re-screened (Screen II), and those showing the greatest progression in intima-media thickness will be invited to participate in a trial run-in to assess vitamin E compliance. Patients will be randomized to the following four groups: 1) vitamin E (573 mg/day); 2) vitamin C; 3) Vitamin E and C combined; and 4) placebo. Common carotid artery intima-media thickness will be observed by ultrasound at 12- and 24-month follow-ups. The primary outcome is 24-month rate of change in average common carotid artery intima-media thickness.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 59 Years
linkedct:eligibility_minimum_age 35 Years
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000600
rdfs:label Trial NCT00000600
linkedct:lastchanged_date October 25, 2006
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000600
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Antioxidants and Prevention of Early Atherosclerosis
linkedct:org_study_id 106
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/25080>
linkedct:overall_status Terminated
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000600>
linkedct:phase Phase 2
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/17747>
linkedct:secondary_id U01 HL52073
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date June 1995
linkedct:study_design Prevention, Randomized, Placebo Control
linkedct:study_type Interventional
linkedct:summary This study will evaluate the effects of vitamin E supplementation in retarding the progression of common carotid artery intima-media thickening in African Americans.
rdf:type linkedct:trials
linkedct:verification_date October 2006