Vitamin K Supplementation in Patients on Hemodialysis
Information source: University Health Network, Toronto
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: End Stage Renal Failure on Dialysis; Atrial Fibrillation
Intervention: vitamin K1 (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University Health Network, Toronto Official(s) and/or principal investigator(s): Marisa Battistella, Principal Investigator, Affiliation: University Health Network, Toronto
Overall contact: Marisa Battistella, Phone: 416-340-4800, Ext: 3207, Email: marisa.battistella@uhn.ca
Summary
The purpose of this study is to determine whether vitamin K supplementation will improve
anticoagulation control in patients on hemodialysis taking warfarin for atrial fibrillation.
Patients who participate will receive vitamin K1 three times a week on dialysis days for a
period of four months. INR levels collected during this period will be compared to the four
month period prior to receiving the vitamin K1 to determine if vitamin K improves the
standard deviation of INRs and time in therapeutic range.
Clinical Details
Official title: Vitamin K Supplementation to Improve INR Stability in Patients on Hemodialysis Taking Warfarin for Atrial Fibrillation
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: INR stability (standard deviation of INR values)
Secondary outcome: Time in Therapeutic Range (Percentage of time INR levels within range)Adverse events
Detailed description:
Patients on hemodialysis with atrial fibrillation are at increased risk of stroke. These
patients often take warfarin to reduce this risk. Warfarin is a drug that is used to prevent
clots in the bloodstream. The dose of warfarin varies from person to person, and its effect
is measured using a blood test called the international normalized ratio (INR). In most
patients with atrial fibrillation the goal is to keep the INR between 2 and 3. Patients on
hemodialysis often have unstable INR levels. Vitamin K supplementation has been shown to
improve INR control in patients on warfarin but has not yet been studied in hemodialysis
patients.
In this study, patients on hemodialysis receiving warfarin for atrial fibrillation will
receive vitamin K 400 mcg orally three times a week on dialysis days for 4 months. INR
levels in the four months before and the four months while receiving vitamin K will be
reviewed.
The primary end point will look at INR stability and be measured by calculating the standard
deviation of INR values before and after receiving vitamin K. The goal of this study is to
determine whether vitamin K supplementation improves INR control in patients on hemodialysis
taking warfarin for atrial fibrillation.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- greater than 18 years of age
- Receiving in-house hemodialysis for at least 6 months
- Previously diagnosed with atrial fibrillation
- On warfarin for at least 6 months with a target INR of 2-3
Exclusion Criteria:
- are unable to provide informed consent
- have a mechanical heart valve
- are receiving supplements containing vitamin K
- have a known hypersensitivity to vitamin K
Locations and Contacts
Marisa Battistella, Phone: 416-340-4800, Ext: 3207, Email: marisa.battistella@uhn.ca
University Health Network, Toronto, Ontario M5G 2C4, Canada; Recruiting Marisa Battistella, Phone: 416-340-4800, Ext: 3207, Email: marisa.battistella@uhn.ca
Additional Information
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Starting date: January 2014
Last updated: January 22, 2015
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