VEAPS: Vitamin E Atherosclerosis Prevention Study
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||VEAPS: Vitamin E Atherosclerosis Prevention Study|
- Rate of change of the distal common carotid artery (CCA) far wall intima-media thickness (IMT)
|Study Start Date:||July 1996|
|Study Completion Date:||September 2000|
|Primary Completion Date:||September 2000 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00114387
|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|