Vitamin K Supplementation in Patients on Hemodialysis

Phase

Condition

Nephropathy

Renal Failure

Kidney Failure (Pediatric)

Treatment

N/A

Clinical Study ID

NCT02324686

14-8200

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

January 01, 2014

December 18, 2017

Study 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.

Connect with a study center

University Health Network
Toronto, Ontario M5G 2C4
Canada
Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.