Vitamin K to Attenuate Coronary Artery Calcification in Hemodialysis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2019-12-31

Brief Summary

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The purpose of this study is to see if vitamin K supplementation three times per week reduces the progression of coronary artery calcification over 12 months in dialysis patients compared to placebo.

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Detailed Description

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At every stage of chronic kidney disease (CKD), the leading cause of mortality is cardiovascular disease. This is due, in part, to vascular calcification (VC) of the coronary arteries. The extent of VC in the coronary arteries of patients with CKD is commonly determined by high resolution CT scan. The total coronary artery calcium (CAC) score, measured in Agatston units (AUs), reflects the calcium burden in the three major coronary arteries and is the current standard for determining extent of vascular calcification in hemodialysis patients. Matrix Gla protein (MGP), a vitamin K dependent protein, is a key inhibitor of vascular calcification and is present in the arterial wall. It is established that MGP becomes up-regulated adjacent to sites of calcification and that vitamin K is critical to its function. Therefore vitamin K status may be critical to the extent of vascular calcification in this patient group. However, to date, no trial has examined whether vitamin K supplementation prevents the progression of coronary artery calcification in patients with kidney failure, a group in which high risk has been established. Therefore, our primary research question is: Does vitamin K supplementation with 10 mg of phylloquinone thrice weekly reduce the progression of coronary artery calcification (as measured by CAC score) over 12 months in prevalent hemodialysis patients with a baseline CAC score of ≥ 30 Agatston Units compared to placebo?

Conditions

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End-stage Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Microcrystalline Methylcellulose

Group Type PLACEBO_COMPARATOR

Microcrystalline Methylcellulose

Intervention Type DRUG

10mg orally three times a week for 12 months

Vitamin K1

Group Type ACTIVE_COMPARATOR

Vitamin K1

Intervention Type DRUG

10mg orally three times a week for 12 months

Interventions

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Vitamin K1

10mg orally three times a week for 12 months

Intervention Type DRUG

Microcrystalline Methylcellulose

10mg orally three times a week for 12 months

Intervention Type DRUG

Other Intervention Names

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Phytonadione Phylloquinone

Eligibility Criteria

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Inclusion Criteria

* Able to provide signed informed consent
* ≥18 years of age
* Expected to survive one year
* Have end-stage kidney disease and require hemodialysis
* Have a baseline coronary artery calcification score ≥30 Agatston units (AUs)

Exclusion Criteria

* Have a medical condition that requires warfarin
* Require hemodialysis for acute kidney injury
* Are Pregnant
* Have other severe co-morbid conditions (e.g. malignancy, disabling stroke) with life expectancy less than one year
* Have undergone coronary artery bypass grafting or have stents placed in their coronary arteries
* Are currently enrolled in another interventional trial

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No