NCT00018460

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Apr 1999

Typical duration for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1999

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 5, 2001

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2002

Completed
Last Updated

January 21, 2009

Status Verified

December 1, 2004

First QC Date

July 3, 2001

Last Update Submit

January 20, 2009

Conditions

Cardiovascular Diseases

Keywords

geriatricsvitamin B complexthrombomodulinanticoagulants

Interventions

Vitamin BDRUG

Eligibility Criteria

Age50 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

VA Maryland Health Care System

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Folic Acid

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

July 3, 2001

First Posted

July 5, 2001

Study Start

April 1, 1999

Study Completion

March 1, 2002

Last Updated

January 21, 2009

Record last verified: 2004-12

Locations

US(1)