VEAPS: Vitamin E Atherosclerosis Prevention Study
2 other identifiers
interventional
353
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 1996
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 1996
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2000
CompletedFirst Submitted
Initial submission to the registry
June 14, 2005
CompletedFirst Posted
Study publicly available on registry
June 15, 2005
CompletedDecember 11, 2009
June 1, 2005
4.2 years
June 14, 2005
December 9, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of change of the distal common carotid artery (CCA) far wall intima-media thickness (IMT)
Interventions
Eligibility Criteria
You may qualify if:
- Male or female
- years or older
- Fasting LDL-C level 130 mg/dL or greater, TG (triglyceride) levels 500mg/dL or lower
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute on Aging (NIA)lead
- Hoffmann-La Rochecollaborator
Study Sites (1)
Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine
Los Angeles, California, 90033, United States
Related Publications (2)
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.
PMID: 12234947RESULTHuang 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.
PMID: 32312759DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Howard N. Hodis, MD
University of Southern California, Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
June 14, 2005
First Posted
June 15, 2005
Study Start
July 1, 1996
Primary Completion
September 1, 2000
Study Completion
September 1, 2000
Last Updated
December 11, 2009
Record last verified: 2005-06