Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00018460
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2001-07-03
Brief Title:
Anticoagulation Vitamins and Endothelial Function
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Anticoagulation Vitamins and Endothelial Function
Status:
COMPLETED
Status Verified Date:
2004-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 17 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None