Atherosclerosis
Conditions
Keywords
vitamin E
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.
Interventions
Sponsors
Hoffmann-La Roche
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of change of the distal common carotid artery (CCA) far wall intima-media thickness (IMT) | — |
Countries
United States
Outcome results
None listed