Anticoagulation, Vitamins, and Endothelial Function

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

NA

Study Classification

INTERVENTIONAL

Study Start Date

1999-04-30

Study Completion Date

2002-03-31

Brief Summary

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Determine whether low or high dose B vitamin therapy will lower homocysteine and thrombomodulin in patients anticoagulated with warfarin.

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Detailed Description

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We hypothesize that 1) both high and low dose B vitamin therapy will lower homocysteine in patients anticoagulated with warfarin and 2) high dose B vitamin therapy will lower thrombomodulin in patients anticoagulated with warfarin. To accomplish these specific aims, we proposed a double- blind randomized controlled trial of 6 months duration comparing 2 different multivitamin regimens differing only in the doses of the following 3 vitamins. The multivitamin for the control group has no folic acid, B2, B6, or B 12. The multivitamin for the intervention group has 5 ing folic acid, 1.7 mg B2, 100 mg B6, and I mg B12. Participants age 50 and older, 150 in each group, are being recruited from the Anticoagulation Clinics at the Baltimore VAMC and neighboring centers. Clinical and risk factor information is being obtained through a face-to-face interview. Blood is being drawn for analyses of homocysteine and vitamin levels (University of Colorado Health Science Center) and thrombomodulin (Baltimore VAMC Hemostasis and Thrombosis Laboratory). Data analysis will be conducted according to the "intention to treat" principle using ordinary least squares regression models.

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Vitamin B

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Males and females ages 50 years or greater

On warfarin therapy for at least 3 months

No active inflammatory process

No physician prescribed B vitamins

Excluded - women of child-bearing age

Minimum Eligible Age

50 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No