Vitamin K to Slow Progression of Cardiovascular Disease Risk in Hemodialysis Patients

What Was Tested

In this not phased trial, researchers set out to test Vitamin D, K2, Magnesium and Zinc.

Recently, there has been growing interest in the vitamin K-dependent matrix Gla protein (MGP) and its role in inhibiting vascular calcification.

It had two arms (groups): Placebo-Control (placebo comparator) and Vitamin K2 (360-mcg/d) (experimental).

The placebo-control group will take four placebo softgel capsules (similar in taste and appearance to the vitamin K2 supplements) every day for 8 weeks.

The experimental group will take four 90-mcg of vitamin K2 (menaquinone-7; 360-mcg) softgel capsules every day for 8 weeks.

The registry classes the interventions as dietary supplement.

Who Took Part

Enrollment: 60 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Chronic Kidney Disease Stages 3 to 5. Receiving hemodialysis treatment for at least 3 months. Subject understands the study protocol and agrees to comply with it. Informed consent documents signed by subject.

The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: using vitamin supplements containing vitamin k; history of metabolic gastrointestinal diseases; subjects presenting chronic degenerative and/or inflammatory diseases.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Vitamin D, K2, Magnesium and Zinc group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Vitamin D, K2, Magnesium and Zinc.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2017-09-13 with completion listed for 2021-12-01.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Flow-Mediated Dilation (FMD) (time frame: Change from baseline to 8 weeks). Pulse Wave Velocity (PWV) (time frame: Change from baseline to 8 weeks).

It also tracked 1 secondary outcome, for example Prothrombin Time.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Vitamin D, K2, Magnesium and Zinc in 60 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Vitamin D, K2, Magnesium and Zinc compound page, all human trials.