Status:
COMPLETED
Low Dose Supplementation to Improve Anticoagulation Control With Oral Vitamin K as an Adjuvant to Warfarin Therapy
Lead Sponsor:
Ottawa Hospital Research Institute
Conditions:
Coagulation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The main objective of this study is to assess the effectiveness of low dose Vitamin K1 (200 micrograms per day) at improving anticoagulation control in unstable patients on warfarin. This study will a...
Detailed Description
A double-blinded placebo controlled pilot RCT assessing the effectiveness of daily supplementation with low dose Vitamin K1 (200 micrograms per day) against placebo at improving anticoagulation contro...
Eligibility Criteria
Inclusion
- \>= 18 years old
- Have been on warfarin anticoagulation for at least 9 months
- Have an INR target range of 2.0-3.0
- Have "unstable" anticoagulation control, defined as in the preceding 6 months having at least 3 INRs out of range (\>= 3.2 or =\<1.8) or at least 3 warfarin dose changes
- Have anticoagulation managed by the Ottawa Hospital Thrombosis Clinic
- Able to provide written, informed consent
Exclusion
- Anticipated interruption or termination of warfarin anticoagulation in the next six months for a period of 1 week or greater
- Patient instability in the preceding six months suspected to be due to a) Interruption of warfarin therapy for a period of 1 week or more or b) Significant non-compliance (assessed from patient record)
- Possess a known allergy to Vitamin K or lactose based placebos
- Unable/Refusal to provide written, informed consent
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2010
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00794755
Start Date
November 1 2008
End Date
April 1 2010
Last Update
July 27 2011
Active Locations (1)
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1
Ottawa Hospital Thrombosis Clinic
Ottawa, Ontario, Canada, K1Y4E9