Status:
COMPLETED
BVAIT: B-Vitamin Atherosclerosis Intervention Trial
Lead Sponsor:
National Institute on Aging (NIA)
Collaborating Sponsors:
Leiner Health Products
Conditions:
Atherosclerosis
Eligibility:
All Genders
40+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to examine whether vitamin B supplementation will reduce the progression of early atherosclerosis in individuals over 40 years old and without clinical evidence of cardiov...
Detailed Description
The primary hypothesis to be tested is that daily vitamin B supplementation reduces progression of early atherosclerosis. Ultrasonography will be used to measure the rate of change in the thickness of...
Eligibility Criteria
Inclusion
- Male or female (postmenopausal)
- 40 years or older
- Fasting plasma homocysteine 8.5 micromoles per liter (µmol/L) or greater
Exclusion
- Any clinical signs or symptoms of cardiovascular disease (CVD)
- Diabetes mellitus or fasting serum glucose 140 mg/dL or greater
- Triglyceride (TG) levels 500mg/dL or greater
- Serum creatinine greater than 1.6 mg/dL
- Uncontrolled hypertension (systolic blood pressure 160 mmHg or greater and/or diastolic blood pressure 100 mmHg or greater)
- Thyroid disease (untreated)
- 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 use, cocaine use)
Key Trial Info
Start Date :
November 1 2000
Trial Type :
INTERVENTIONAL
End Date :
February 1 2007
Estimated Enrollment :
506 Patients enrolled
Trial Details
Trial ID
NCT00114400
Start Date
November 1 2000
End Date
February 1 2007
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