BVAIT: B-Vitamin Atherosclerosis Intervention Trial

Atherosclerosis Clinical Trial

Official title:

B-Vitamin Atherosclerosis Intervention Trial (BVAIT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00114400
• Other study ID #: AG0024
• Secondary ID: R01AG017160
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 14, 2005
• Last updated: December 9, 2009
• Start date: November 2000
• Est. completion date: February 2007

Study information

• Verified date: February 2007
• Source: National Institute on Aging (NIA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 506
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Drug:
• folic acid

• vitamin B12

• vitamin B6

Locations

Country	Name	City	State
United States	Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
National Institute on Aging (NIA)	Leiner Health Products

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of change of distal common carotid artery (CCA) far wall intima-media thickness (IMT)
Secondary	change in coronary and abdominal aortic calcification
Secondary	neurocognitive change