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Anticoagulation, Vitamins, and Endothelial Function

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00018460
First Posted: July 5, 2001
Last Update Posted: January 21, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
VA Office of Research and Development
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Anticoagulation, Vitamins, and Endothelial Function

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00018460


Locations
United States, Maryland
VA Maryland Health Care System
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
VA Office of Research and Development
  More Information

ClinicalTrials.gov Identifier: NCT00018460     History of Changes
Other Study ID Numbers: Epid-004-98F
First Submitted: July 3, 2001
First Posted: July 5, 2001
Last Update Posted: January 21, 2009
Last Verified: December 2004

Keywords provided by VA Office of Research and Development:
geriatrics
vitamin B complex
thrombomodulin
anticoagulants

Additional relevant MeSH terms:
Cardiovascular Diseases
Vitamins
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs