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BVAIT: B-Vitamin Atherosclerosis Intervention Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00114400
Recruitment Status : Completed
First Posted : June 15, 2005
Last Update Posted : December 11, 2009
Sponsor:
Collaborator:
Leiner Health Products
Information provided by:
National Institute on Aging (NIA)

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Atherosclerosis Drug: folic acid Drug: vitamin B12 Drug: vitamin B6 Phase 2 Phase 3

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 506 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: B-Vitamin Atherosclerosis Intervention Trial (BVAIT)
Study Start Date : November 2000
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. rate of change of distal common carotid artery (CCA) far wall intima-media thickness (IMT)

Secondary Outcome Measures :
  1. change in coronary and abdominal aortic calcification
  2. neurocognitive change

Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00114400


Locations
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United States, California
Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine
Los Angeles, California, United States, 90033
Sponsors and Collaborators
National Institute on Aging (NIA)
Leiner Health Products
Investigators
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Principal Investigator: Howard N. Hodis, MD University of Southern California, Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00114400    
Other Study ID Numbers: AG0024
R01AG017160 ( U.S. NIH Grant/Contract )
First Posted: June 15, 2005    Key Record Dates
Last Update Posted: December 11, 2009
Last Verified: February 2007
Keywords provided by National Institute on Aging (NIA):
cardiovascular disease
CVD
Additional relevant MeSH terms:
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Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Vitamins
Folic Acid
Vitamin B 12
 Vitamin B 6
Pyridoxal
Pyridoxine
Vitamin B Complex
Micronutrients
Physiological Effects of Drugs
Hematinics