VEAPS: Vitamin E Atherosclerosis Prevention Study

Sponsor

National Institute on Aging (NIA) (NIH)

Overall Status

Completed

CT.gov ID

NCT00114387

Collaborator

Hoffmann-La Roche (Industry)

353

Enrollment

Location

Duration (Months)

7.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis	Drug: DL-alpha-tocopherol	Phase 2/Phase 3

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Prevention

Official Title:

VEAPS: Vitamin E Atherosclerosis Prevention Study

Study Start Date :

Jul 1, 1996

Actual Primary Completion Date :

Sep 1, 2000

Actual Study Completion Date :

Sep 1, 2000

Outcome Measures

Primary Outcome Measures

Rate of change of the distal common carotid artery (CCA) far wall intima-media thickness (IMT) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine	Los Angeles	California	United States	90033

Sponsors and Collaborators

National Institute on Aging (NIA)
Hoffmann-La Roche

Investigators

Principal Investigator: Howard N. Hodis, MD, University of Southern California, Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine