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Sponsors and Collaborators: |
National Institute on Aging (NIA) Hoffmann-La Roche |
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Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00114387 |
The purpose of this study is to examine whether vitamin E (DL-alpha-tocopherol) supplementation will reduce the progression of early atherosclerosis in healthy individuals over 40 years of age with low-density lipoprotein (LDL) cholesterol levels greater than or equal to 130mg/dL.
Condition | Intervention | Phase |
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Atherosclerosis |
Drug: DL-alpha-tocopherol |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | VEAPS: Vitamin E Atherosclerosis Prevention Study |
Estimated Enrollment: | 353 |
Study Start Date: | July 1996 |
Estimated Study Completion Date: | September 2000 |
The primary hypothesis to be tested is that vitamin E supplementation of 400 IU/day exerts positive arterial wall effects by reducing progression of early atherosclerosis in healthy individuals 40 years old or older without clinical evidence of cardiovascular disease (CVD). Ultrasonography will be used to measure the rate of change of the distal common carotid artery (CCA) far wall intima-media thickness (IMT). The beneficial effects of vitamin E supplementation are expected to occur with or without a change in LDL-C levels.
A total of 353 men and women will be recruited for the three-year trial. Participants will be randomized into a treatment group to receive either vitamin E (DL-alpha-tocopherol) 400 IU/day or a placebo. The ultrasound measurement of CCA IMT will be repeated every six months for two years.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine | |
Los Angeles, California, United States, 90033 |
Principal Investigator: | Howard N. Hodis, MD | University of Southern California, Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine |
Study ID Numbers: | AG0023, R01AG13860 |
Study First Received: | June 14, 2005 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00114387 |
Health Authority: | United States: Federal Government |
vitamin E |
Tocopherols Arterial Occlusive Diseases Atherosclerosis Tocopherol acetate |
Vitamin E Vascular Diseases Arteriosclerosis Alpha-Tocopherol |
Antioxidants Molecular Mechanisms of Pharmacological Action Growth Substances Vitamins Physiological Effects of Drugs |
Cardiovascular Diseases Micronutrients Protective Agents Pharmacologic Actions |