VEAPS: Vitamin E Atherosclerosis Prevention Study

Atherosclerosis Clinical Trial

Official title:

VEAPS: Vitamin E Atherosclerosis Prevention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00114387
• Other study ID #: AG0023
• Secondary ID: R01AG013860
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 14, 2005
• Last updated: December 9, 2009
• Start date: July 1996
• Est. completion date: September 2000

Study information

• Verified date: June 2005
• Source: National Institute on Aging (NIA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 353
• Est. completion date: September 2000
• Est. primary completion date: September 2000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Drug:
• DL-alpha-tocopherol

Locations

Country	Name	City	State
United States	Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
National Institute on Aging (NIA)	Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of change of the distal common carotid artery (CCA) far wall intima-media thickness (IMT)