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Completed

NCT Number: NCT02324686

Vitamin K Supplementation in Patients on Hemodialysis

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.

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Key information

Conditions

End Stage Renal Failure on Dialysis Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin K1

Drug

Vitamin K1 400 mcg orally three times a week on dialysis days for four months

Other names: phytonadione

Primary outcomes

  1. INR stability (standard deviation of INR values)

    Time frame: 4 months before and 4 months after intervention

    standard deviation of INR values, 4 months before and 4 months after the intervention

Secondary outcomes

  1. Time in Therapeutic Range (Percentage of time INR levels within range)

    Time frame: 4 months before and 4 months after intervention

    , 4 months before and 4 months after the intervention

  2. Adverse events

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Acronym: VISTA

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 24, 2014
Registry last updated
Feb 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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