Vitamin E and C to Slow Progression of Common Carotid Artery Plaque Build-Up
|First Received Date ICMJE||October 27, 1999|
|Last Updated Date||December 12, 2013|
|Start Date ICMJE||June 1995|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||rate of change in average common carotid artery intima-media thickness (measured over 24 months)|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00000600 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Vitamin E and C to Slow Progression of Common Carotid Artery Plaque Build-Up|
|Official Title ICMJE||Antioxidants and Prevention of Early Atherosclerosis|
This study will evaluate the effects of vitamin E supplementation in retarding the progression of common carotid artery intima-media thickening in African Americans.
Evidence from epidemiologic studies, and from one unpublished study, suggests that greater intake of antioxidant vitamins is associated with reduced risk of coronary heart disease and stroke.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.
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.
The study completion date listed in this record was obtained from the Query/View/Report (QVR) System.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Allocation: Randomized
Primary Purpose: Prevention
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Terminated|
|Enrollment ICMJE||Not Provided|
|Completion Date||May 2000|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||35 Years to 59 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Not Provided|
|NCT Number ICMJE||NCT00000600|
|Other Study ID Numbers ICMJE||106, U01 HL52073|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Heart, Lung, and Blood Institute (NHLBI)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Heart, Lung, and Blood Institute (NHLBI)|
|Verification Date||October 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP