BVAIT: B-Vitamin Atherosclerosis Intervention Trial
B-Vitamin Atherosclerosis Intervention Trial (BVAIT)
2 other identifiers
interventional
506
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2000
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2000
CompletedFirst Submitted
Initial submission to the registry
June 14, 2005
CompletedFirst Posted
Study publicly available on registry
June 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedDecember 11, 2009
February 1, 2007
6.3 years
June 14, 2005
December 9, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
rate of change of distal common carotid artery (CCA) far wall intima-media thickness (IMT)
Secondary Outcomes (2)
change in coronary and abdominal aortic calcification
neurocognitive change
Interventions
Eligibility Criteria
You may qualify if:
- Male or female (postmenopausal)
- years or older
- Fasting plasma homocysteine 8.5 micromoles per liter (µmol/L) or greater
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute on Aging (NIA)lead
- Leiner Health Productscollaborator
Study Sites (1)
Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine
Los Angeles, California, 90033, United States
Related Publications (2)
Lin F, Pa J, Karim R, Hodis HN, Han SD, Henderson VW, St John JA, Mack WJ. Subclinical carotid artery atherosclerosis and cognitive function in older adults. Alzheimers Res Ther. 2022 May 7;14(1):63. doi: 10.1186/s13195-022-00997-7.
PMID: 35526057DERIVEDHodis HN, Mack WJ, Dustin L, Mahrer PR, Azen SP, Detrano R, Selhub J, Alaupovic P, Liu CR, Liu CH, Hwang J, Wilcox AG, Selzer RH; BVAIT Research Group. High-dose B vitamin supplementation and progression of subclinical atherosclerosis: a randomized controlled trial. Stroke. 2009 Mar;40(3):730-6. doi: 10.1161/STROKEAHA.108.526798. Epub 2008 Dec 31.
PMID: 19118243DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Howard N. Hodis, MD
University of Southern California, Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
June 14, 2005
First Posted
June 15, 2005
Study Start
November 1, 2000
Primary Completion
February 1, 2007
Study Completion
February 1, 2007
Last Updated
December 11, 2009
Record last verified: 2007-02