Anticoagulation, Vitamins, and Endothelial Function

Cardiovascular Diseases Clinical Trial

Official title:

Anticoagulation, Vitamins, and Endothelial Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00018460
• Other study ID #: Epid-004-98F
• Status: Completed
• Phase: N/A
• First received: July 3, 2001
• Last updated: January 20, 2009
• Start date: April 1999
• Est. completion date: March 2002

Study information

• Verified date: December 2004
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 95 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Drug:
• Vitamin B

Locations

Country	Name	City	State
United States	VA Maryland Health Care System	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States,