VEAPS: Vitamin E Atherosclerosis Prevention Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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VEAPS: Vitamin E Atherosclerosis Prevention Study

Conditions
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Atherosclerosis

Intervention / Treatment
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* Drug: DL-alpha-tocopherol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 40 years or older Fasting LDL-C level 130 mg/dL or greater, TG (triglyceride) levels 500mg/dL or lower Exclusion Criteria: Any clinical signs or symptoms of cardiovascular disease (CVD) Diabetes mellitus or fasting serum glucose 140mg/dL or greater Regular vitamin E supplementation for more than 1 year Lipid standardized plasma vitamin E levels greater than 35 micromoles per liter (μmol/L) Uncontrolled hypertension (diastolic blood pressure 100 mmHg or greater) Thyroid disease (untreated) Renal insufficiency (serum creatinine greater than 2.5 mg/dL) Life threatening disease with prognosis less than 5 years Alcohol intake greater than 5 drinks per day (1 drink = 1 1/2 oz distilled spirits, 4 oz wine, or 12 oz beer) or substance abuse (intravenous drug abuse, cocaine use)

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: DL-alpha-tocopherol|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of change of the distal common carotid artery (CCA) far wall intima-media thickness (IMT) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin E