VEAPS: Vitamin E Atherosclerosis Prevention Study - Full Text View

Sponsor:	National Institute on Aging (NIA)
Collaborator:	Hoffmann-La Roche
Information provided by:	National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:	NCT00114387

Purpose

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	Intervention	Phase
Atherosclerosis	Drug: DL-alpha-tocopherol	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention
Official Title:	VEAPS: Vitamin E Atherosclerosis Prevention Study

Resource links provided by NLM:

MedlinePlus related topics: Atherosclerosis Vitamin E

Drug Information available for: alpha-Tocopherol DL-alpha-Tocopherol Vitamin E Tocopherols Tocotrienol

U.S. FDA Resources

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:

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

Estimated Enrollment:	353
Study Start Date:	July 1996
Study Completion Date:	September 2000
Primary Completion Date:	September 2000 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00114387

Locations

United States, California
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

More Information

Publications:

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.

ClinicalTrials.gov Identifier:	NCT00114387 History of Changes
Other Study ID Numbers:	AG0023, R01AG13860
Study First Received:	June 14, 2005
Last Updated:	December 9, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Aging (NIA):

vitamin E

Additional relevant MeSH terms:

Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Alpha-Tocopherol
Vitamin E
Tocopherols
Tocotrienols

Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on February 09, 2012