VEAPS: Vitamin E Atherosclerosis Prevention Study

National Institutes of Health (NIH)

Status and phase

Completed

Phase 3

Phase 2

Conditions

Atherosclerosis

Treatments

Drug: DL-alpha-tocopherol

Study type

Interventional

Funder types

Industry

NIH

Identifiers

NCT00114387

R01AG013860 (U.S. NIH Grant/Contract)

AG0023

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

40+ years old

Volunteers

Accepts Healthy Volunteers

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)