BVAIT: B-Vitamin Atherosclerosis Intervention Trial

Completed

Phase 2/3 Results

Trial Description

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

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).

Conditions

Interventions

  • Folic Acid (Folate, Folacin,)Drug
  • Vitamin B6 Drug
  • Vitamin B 12 Drug
    Intervention Desc: Helps maintain healthy nerve cells and red blood cells. It is also needed to help make DNA, the genetic material in all cells.
  • Vitamin B12 Drug

Trial Design

  • Allocation: Randomized
  • Masking: Double-Blind
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

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).

Outcomes

Type Measure 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; neurocognitive change.
Secondary change in coronary and abdominal aortic calcification
Secondary neurocognitive change

Sponsors