VEAPS: Vitamin E Atherosclerosis Prevention Study
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ClinicalTrials.gov Identifier: NCT00114387 |
Recruitment Status :
Completed
First Posted : June 15, 2005
Last Update Posted : December 11, 2009
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Tracking Information | ||||
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First Submitted Date ICMJE | June 14, 2005 | |||
First Posted Date ICMJE | June 15, 2005 | |||
Last Update Posted Date | December 11, 2009 | |||
Study Start Date ICMJE | July 1996 | |||
Actual Primary Completion Date | September 2000 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Rate of change of the distal common carotid artery (CCA) far wall intima-media thickness (IMT) | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | VEAPS: Vitamin E Atherosclerosis Prevention Study | |||
Official Title ICMJE | VEAPS: Vitamin E Atherosclerosis Prevention Study | |||
Brief Summary | 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. | |||
Detailed Description | 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. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 Phase 3 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Prevention |
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Condition ICMJE | Atherosclerosis | |||
Intervention ICMJE | Drug: DL-alpha-tocopherol | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Hodis HN, Mack WJ, LaBree L, Mahrer PR, Sevanian A, Liu CR, Liu CH, Hwang J, Selzer RH, Azen SP; VEAPS Research Group. Alpha-tocopherol supplementation in healthy individuals reduces low-density lipoprotein oxidation but not atherosclerosis: the Vitamin E Atherosclerosis Prevention Study (VEAPS). Circulation. 2002 Sep 17;106(12):1453-9. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE |
353 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | September 2000 | |||
Actual Primary Completion Date | September 2000 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 40 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00114387 | |||
Other Study ID Numbers ICMJE | AG0023 R01AG013860 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | National Institute on Aging (NIA) | |||
Collaborators ICMJE | Hoffmann-La Roche | |||
Investigators ICMJE |
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PRS Account | National Institute on Aging (NIA) | |||
Verification Date | June 2005 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |