Anticoagulation, Vitamins, and Endothelial Function - Tabular View

Tracking Information
First Received Date ^ICMJE	July 3, 2001
Last Updated Date	January 20, 2009
Start Date ^ICMJE	April 1999
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00018460 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Anticoagulation, Vitamins, and Endothelial Function
Official Title ^ICMJE	Anticoagulation, Vitamins, and Endothelial Function
Brief Summary	Determine whether low or high dose B vitamin therapy will lower homocysteine and thrombomodulin in patients anticoagulated with warfarin.
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.
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Allocation: Randomized Control: Placebo Control Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Prevention
Condition ^ICMJE	Cardiovascular Diseases
Intervention ^ICMJE	Drug: Vitamin B
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date	March 2002
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	50 Years to 95 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00018460
Responsible Party
Study ID Numbers ^ICMJE	Epid-004-98F
Study Sponsor ^ICMJE	Department of Veterans Affairs
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Department of Veterans Affairs
Verification Date	December 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP