BVAIT: B-Vitamin Atherosclerosis Intervention Trial

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

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 cardiovascular disease (CVD).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute on Aging (NIA)
• Collaborator: Leiner Health Products
• Treatments: Folic Acid; Hydroxocobalamin; Pyridoxal; Pyridoxine; Vitamin B 12; Vitamin B 6; Vitamin B Complex; Vitamins

Criteria

Inclusion Criteria:

• Male or female (postmenopausal)

• 40 years or older

• Fasting plasma homocysteine 8.5 micromoles per liter (µmol/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)