Vitamin K Supplementation in Patients on Hemodialysis

Phase 2

Completed

• Conditions: End Stage Renal Failure on Dialysis; Atrial Fibrillation
• Interventions: Drug: vitamin K1

• Registration Number: NCT02324686
• Lead Sponsor: University Health Network, Toronto

Brief 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.

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-12-19
• Study First Submitted QC: 2014-12-23
• Study First Posted: 2014-12-24
• Status Verified: 2016-05
• Primary Completion: 2017-12-18
• Study Completion: 2017-12-18
• Last Update Submitted: 2018-02-02
• Last Update Posted: 2018-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitamin K1	vitamin K1	Vitamin K1 400 mcg orally three times a week on dialysis days for four months

Primary Outcome Measures

Name	Time	Method
INR stability (standard deviation of INR values)	4 months before and 4 months after intervention	standard deviation of INR values, 4 months before and 4 months after the intervention

Secondary Outcome Measures

Name	Time	Method
Time in Therapeutic Range (Percentage of time INR levels within range)	4 months before and 4 months after intervention	, 4 months before and 4 months after the intervention
Adverse events	4 months before and 4 months after intervention	Number and types of thromboembolic and bleeding complications, 4 months before and 4 months after the intervention

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada