BVAIT: B-Vitamin Atherosclerosis Intervention Trial


Phase 2/3 Results

Eligibility Criteria

Inclusion Criteria

- Male or female (postmenopausal)
- 40 years or older
- Fasting plasma homocysteine 8.5 micromoles per liter (┬Ámol/L) or greater

Exclusion Criteria

- 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)