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Sponsors and Collaborators: |
National Institute on Aging (NIA) Leiner Health Products |
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Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00114400 |
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).
Condition | Intervention | Phase |
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Atherosclerosis |
Drug: folic acid Drug: vitamin B12 Drug: vitamin B6 |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | B-Vitamin Atherosclerosis Intervention Trial (BVAIT) |
Estimated Enrollment: | 506 |
Study Start Date: | November 2000 |
Estimated Study Completion Date: | February 2007 |
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).
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine | |
Los Angeles, California, United States, 90033 |
Principal Investigator: | Howard N. Hodis, MD | University of Southern California, Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine |
Study ID Numbers: | AG0024, R01AG017160 |
Study First Received: | June 14, 2005 |
Last Updated: | February 15, 2007 |
ClinicalTrials.gov Identifier: | NCT00114400 |
Health Authority: | United States: Federal Government |
cardiovascular disease CVD |
Folic Acid Arterial Occlusive Diseases Atherosclerosis Hydroxocobalamin Vascular Diseases |
Vitamin B 12 Pyridoxine Arteriosclerosis Vitamin B 6 |
Vitamin B Complex Hematinics Therapeutic Uses Growth Substances Vitamins |
Hematologic Agents Physiological Effects of Drugs Cardiovascular Diseases Micronutrients Pharmacologic Actions |