Vitamin K Supplementation in Patients on Hemodialysis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Vitamin K Supplementation to Improve INR Stability in Patients on Hemodialysis Taking Warfarin for Atrial Fibrillation

Conditions
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End Stage Renal Failure on Dialysis, Atrial Fibrillation

Intervention / Treatment
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* Drug: vitamin K1


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Vitamin K1<br>Vitamin K1 400 mcg orally three times a week on dialysis days for four months | Drug: vitamin K1<br>* Vitamin K1 400 mcg orally three times a week on dialysis days for four months<br>* Other names: phytonadione;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| INR stability (standard deviation of INR values) | standard deviation of INR values, 4 months before and 4 months after the intervention | 4 months before and 4 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in Therapeutic Range (Percentage of time INR levels within range) | , 4 months before and 4 months after the intervention | 4 months before and 4 months after intervention | 
| Adverse events | Number and types of thromboembolic and bleeding complications, 4 months before and 4 months after the intervention | 4 months before and 4 months after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Warfarin, International Normalized Ratio, Vitamin K