VEAPS: Vitamin E Atherosclerosis Prevention Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00114387|
Recruitment Status : Completed
First Posted : June 15, 2005
Last Update Posted : December 11, 2009
|Condition or disease||Intervention/treatment||Phase|
|Atherosclerosis||Drug: DL-alpha-tocopherol||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||353 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||VEAPS: Vitamin E Atherosclerosis Prevention Study|
|Study Start Date :||July 1996|
|Actual Primary Completion Date :||September 2000|
|Actual Study Completion Date :||September 2000|
- Rate of change of the distal common carotid artery (CCA) far wall intima-media thickness (IMT)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|