VEAPS: Vitamin E Atherosclerosis Prevention Study

• Status: Completed
• Trial end date: 2000-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute on Aging (NIA)
• Collaborator: Hoffmann-La Roche
• Treatments: alpha-Tocopherol; Tocopherols; Tocotrienols; Vitamin E; Vitamins

Criteria

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)