Vitamin E and C to Slow Progression of Common Carotid Artery Plaque Build-Up

This study has been terminated.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00000600
First received: October 27, 1999
Last updated: December 12, 2013
Last verified: October 2006

October 27, 1999
December 12, 2013
June 1995
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rate of change in average common carotid artery intima-media thickness (measured over 24 months)
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Complete list of historical versions of study NCT00000600 on ClinicalTrials.gov Archive Site
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Vitamin E and C to Slow Progression of Common Carotid Artery Plaque Build-Up
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.

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Evidence from epidemiologic studies, and from one unpublished study, suggests that greater intake of antioxidant vitamins is associated with reduced risk of coronary heart disease and stroke.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.

The study completion date listed in this record was obtained from the Query/View/Report (QVR) System.

Interventional
Phase 2
Allocation: Randomized
Primary Purpose: Prevention
  • Cardiovascular Diseases
  • Carotid Artery Diseases
  • Intracranial Arteriosclerosis
  • Cerebrovascular Disorders
  • Heart Diseases
  • Vascular Diseases
  • Atherosclerosis
  • Drug: Vitamin E
  • Drug: Vitamin C
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
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May 2000
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Inclusion Criteria:

  • African American
Both
35 Years to 59 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00000600
106, U01 HL52073
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National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: James H. Dwyer, III University of Southern California
National Heart, Lung, and Blood Institute (NHLBI)
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP