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Anticoagulation, Vitamins, and Endothelial Function

This study has been completed.

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00018460
  Purpose

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


Condition Intervention
Cardiovascular Diseases
Drug: Vitamin B

MedlinePlus related topics:   Blood Thinners   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:   Anticoagulation, Vitamins, and Endothelial Function

Further study details as provided by Department of Veterans Affairs:

Study Start Date:   April 1999
Estimated Study Completion Date:   March 2002

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   50 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00018460

Locations
United States, Maryland
VA Maryland Health Care System    
      Baltimore, Maryland, United States, 21201

Sponsors and Collaborators
  More Information


Study ID Numbers:   Epid-004-98F
First Received:   July 3, 2001
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00018460
Health Authority:   United States: Federal Government

Keywords provided by Department of Veterans Affairs:
geriatrics  
vitamin B complex  
thrombomodulin  
anticoagulants  

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 20, 2008




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