search
Back to results

BVAIT: B-Vitamin Atherosclerosis Intervention Trial

Primary Purpose

Atherosclerosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
folic acid
vitamin B12
vitamin B6
Sponsored by
National Institute on Aging (NIA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atherosclerosis focused on measuring cardiovascular disease, CVD

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine

Outcomes

Primary Outcome Measures

rate of change of distal common carotid artery (CCA) far wall intima-media thickness (IMT)

Secondary Outcome Measures

change in coronary and abdominal aortic calcification
neurocognitive change

Full Information

First Posted
June 14, 2005
Last Updated
December 9, 2009
Sponsor
National Institute on Aging (NIA)
Collaborators
Leiner Health Products
search

1. Study Identification

Unique Protocol Identification Number
NCT00114400
Brief Title
BVAIT: B-Vitamin Atherosclerosis Intervention Trial
Official Title
B-Vitamin Atherosclerosis Intervention Trial (BVAIT)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
November 2000 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Aging (NIA)
Collaborators
Leiner Health Products

4. Oversight

5. Study Description

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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis
Keywords
cardiovascular disease, CVD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
506 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
folic acid
Intervention Type
Drug
Intervention Name(s)
vitamin B12
Intervention Type
Drug
Intervention Name(s)
vitamin B6
Primary Outcome Measure Information:
Title
rate of change of distal common carotid artery (CCA) far wall intima-media thickness (IMT)
Secondary Outcome Measure Information:
Title
change in coronary and abdominal aortic calcification
Title
neurocognitive change

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard N. Hodis, MD
Organizational Affiliation
University of Southern California, Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35526057
Citation
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.
Results Reference
derived
PubMed Identifier
19118243
Citation
Hodis 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.
Results Reference
derived

Learn more about this trial

BVAIT: B-Vitamin Atherosclerosis Intervention Trial

We'll reach out to this number within 24 hrs