BVAIT: B-Vitamin Atherosclerosis Intervention Trial

Study Overview
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Brief Summary
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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).

Detailed Description
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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 the carotid artery and CT will be used to measure coronary and aortic calcium. The beneficial effects of vitamin B supplementation are expected to occur with or without a change in LDL-C levels. A total of 506 men and women will be randomized to receive either 1) vitamin B supplementation consisting of folic acid 5mg, vitamin B12 0.4mg, and vitamin B6 50mg, or 2) a matching placebo. Participants will receive ultrasonography at baseline and every 6 months for 2.5 to 4.5 years, and CT scan at baseline and end of study (2.5 to 4.5 years).

Official Title
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B-Vitamin Atherosclerosis Intervention Trial (BVAIT)

Conditions
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Atherosclerosis

Intervention / Treatment
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* Drug: folic acid
* Drug: vitamin B12
* Drug: vitamin B6


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: folic acid|nan|
|Drug: vitamin B12|nan|
|Drug: vitamin B6|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of change of distal common carotid artery (CCA) far wall intima-media thickness (IMT) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in coronary and abdominal aortic calcification |  |  | 
| neurocognitive change |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiovascular disease, CVD