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BVAIT: B-Vitamin Atherosclerosis Intervention Trial

NCT ID: NCT00114400

Last Updated: 2009-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

506 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-11-30

Study Completion Date

2007-02-28

Brief Summary

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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

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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

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Atherosclerosis

Keywords

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cardiovascular disease CVD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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folic acid

Intervention Type DRUG

vitamin B12

Intervention Type DRUG

vitamin B6

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Leiner Health Products

INDUSTRY

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role lead

Principal Investigators

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Howard N. Hodis, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California, Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine

Locations

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

Los Angeles, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35526057 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19118243 (View on PubMed)

Other Identifiers

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R01AG017160

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AG0024

Identifier Type: -

Identifier Source: org_study_id