VEAPS: Vitamin E Atherosclerosis Prevention Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

353 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-07-31

Study Completion Date

2000-09-30

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.

Conditions

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Atherosclerosis

Keywords

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vitamin E

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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DL-alpha-tocopherol

Intervention Type DRUG

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)

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Howard N. Hodis, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California, Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine

Locations

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Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine

Los Angeles, California, United States

Site Status

Countries

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United States

References

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Hodis HN, Mack WJ, LaBree L, Mahrer PR, Sevanian A, Liu CR, Liu CH, Hwang J, Selzer RH, Azen SP; VEAPS Research Group. Alpha-tocopherol supplementation in healthy individuals reduces low-density lipoprotein oxidation but not atherosclerosis: the Vitamin E Atherosclerosis Prevention Study (VEAPS). Circulation. 2002 Sep 17;106(12):1453-9. doi: 10.1161/01.cir.0000029092.99946.08.

Reference Type RESULT

PMID: 12234947 (View on PubMed)

Huang J, Hodis HN, Weinstein SJ, Mack WJ, Sampson JN, Mondul AM, Albanes D. Serum Metabolomic Response to Low- and High-Dose Vitamin E Supplementation in Two Randomized Controlled Trials. Cancer Epidemiol Biomarkers Prev. 2020 Jul;29(7):1329-1334. doi: 10.1158/1055-9965.EPI-20-0187. Epub 2020 Apr 20.

Reference Type DERIVED

PMID: 32312759 (View on PubMed)

Other Identifiers

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R01AG013860

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AG0023

Identifier Type: -

Identifier Source: org_study_id