Status:
COMPLETED
VEAPS: Vitamin E Atherosclerosis Prevention Study
Lead Sponsor:
National Institute on Aging (NIA)
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Atherosclerosis
Eligibility:
All Genders
40+ years
Phase:
PHASE2
PHASE3
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 lo...
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 yea...
Eligibility Criteria
Inclusion
- Male or female
- 40 years or older
- Fasting LDL-C level 130 mg/dL or greater, TG (triglyceride) levels 500mg/dL or lower
Exclusion
- 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)
Key Trial Info
Start Date :
July 1 1996
Trial Type :
INTERVENTIONAL
End Date :
September 1 2000
Estimated Enrollment :
353 Patients enrolled
Trial Details
Trial ID
NCT00114387
Start Date
July 1 1996
End Date
September 1 2000
Last Update
December 11 2009
Active Locations (1)
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1
Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine
Los Angeles, California, United States, 90033