VEAPS: Vitamin E Atherosclerosis Prevention Study

• ClinicalTrials.gov Identifier: NCT00114387
• Recruitment Status: Completed
• First Posted: June 15, 2005
• Last Update Posted: December 11, 2009
• Sponsor: National Institute on Aging (NIA)
• Collaborator: Hoffmann-La Roche
• Information provided by: National Institute on Aging (NIA)

Tracking Information

• First Submitted Date: June 14, 2005
• First Posted Date: June 15, 2005
• Last Update Posted Date: December 11, 2009
• Study Start Date: July 1996
• Actual Primary Completion Date: September 2000 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 23, 2005): Rate of change of the distal common carotid artery (CCA) far wall intima-media thickness (IMT)
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: VEAPS: Vitamin E Atherosclerosis Prevention Study
• Official Title: VEAPS: Vitamin E Atherosclerosis Prevention Study
• 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.

• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Prevention
• Condition: Atherosclerosis
• Intervention: Drug: DL-alpha-tocopherol
• Study Arms: Not Provided

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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: June 23, 2005): 353
• Original Enrollment: Same as current
• Actual Study Completion Date: September 2000
• Actual Primary Completion Date: September 2000 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00114387
• Other Study ID Numbers: AG0023; R01AG013860 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: National Institute on Aging (NIA)
• Collaborators: Hoffmann-La Roche

Investigators

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

• PRS Account: National Institute on Aging (NIA)
• Verification Date: June 2005