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