Vitamin K2 and Vessel Calcification in Chronic Kidney Disease Patients

What Was Tested

This registered phase 4 trial tested Vitamin D, K2, Magnesium and Zinc.

Vessel calcification is a recognised cardiovascular morbidity risk factor in patients with chronic kidney disease (CKD).

MGP is excretion protein whose mechanism of action is not yet fully explained and which to be activated requires phosphorylation and carboxylation where cofactor is vitamin K.

It had two arms (groups): Vitamin K2, calcification score changes, vitamin D (active comparator) and Vitamin D, calcium score changes (active comparator).

The registry classes the interventions as drug.

More on the Plan

On the other hand CKD patients often display shortages of this vitamin.

There are currently no similar studies in patients with chronic kidney disease who do not require renal replacement therapy.

Patients with calcium score \>10 (Agatston scoring system) will be qualified for the study.

Patients and their basic laboratory test will be evaluated during the study period by a nephrologists on a monthly basis.

Who Took Part

60 planned participants were the target.

It was open to people of any sex aged from 30 years up to 70 years.

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

Examples of who could join: Patient has a life without dialysis therapy of more than 9 months. Subject in 30-70 years of age. Calcium score \>10 (as per Agatston scoring system).

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: atherosclerosis generalisata (myocardial infarction treated with ptca - percutaneous transluminal coronary angioplasty or cabg - coronary artery bypass graft, symptomatic heart insufficiency, cerebrovascular accident); subject with a history of cardiac abnormalities, including symptomatic or asymptomatic arrhythmias (atrial fibrillation); patient with cardiac pacemaker.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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.

As a double-blind Vitamin D, K2, Magnesium and Zinc study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2009-06 with completion listed for 2010-12.

It ran at 1 site in Poland.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Changes in coronary artery calcification score (time frame: 9 months).

It also tracked 1 secondary outcome, for example Changes in common carotid artery intima media thickness.

What This Means in Plain Language

Put simply, this is a phase 4, 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.