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VEAPS: Vitamin E Atherosclerosis Prevention Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00114387
Recruitment Status : Completed
First Posted : June 15, 2005
Last Update Posted : December 11, 2009
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
National Institute on Aging (NIA)

Tracking Information
First Submitted Date  ICMJE June 14, 2005
First Posted Date  ICMJE June 15, 2005
Last Update Posted Date December 11, 2009
Study Start Date  ICMJE July 1996
Actual Primary Completion Date September 2000   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)		 Rate of change of the distal common carotid artery (CCA) far wall intima-media thickness (IMT)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE VEAPS: Vitamin E Atherosclerosis Prevention Study
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE Atherosclerosis
Intervention  ICMJE Drug: DL-alpha-tocopherol
Study Arms  ICMJE 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 23, 2005)		 353
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2000
Actual Primary Completion Date September 2000   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00114387
Other Study ID Numbers  ICMJE AG0023
R01AG013860 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Institute on Aging (NIA)
Collaborators  ICMJE Hoffmann-La Roche
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP