Effects of menaquinone-7 supplementation in patients with aortic valve calcification: study protocol for a randomised controlled trial

What Was Tested

This clinical study looks at Vitamin D, K2, Magnesium and Zinc.

To evaluate AVC score, a non-contrast CT scan is performed at baseline and repeated after 12 and 24 months of follow-up.

Why It Was Studied

This study will examine the effect of menaquinone-7 (MK-7) supplementation on progression of aortic valve calcification (AVC).

The researchers hypothesise that MK-7 supplementation will slow down the calcification process.

Who Took Part

The abstract describes 400 men taking part.

By PubMed's age tags, the people studied were older adults, men only.

Exclusion criteria are treatment with vitamin K antagonist or coagulation disorders.

How the Study Was Run

The researchers set it up as a randomized, double-blind, placebo-controlled and multicenter study.

Because people in this Vitamin D, K2, Magnesium and Zinc study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Neither the men nor the staff measuring them knew who was on Vitamin D, K2, Magnesium and Zinc, so expectations could not easily colour the readings.

Some men received a placebo instead of Vitamin D, K2, Magnesium and Zinc, giving a reference point.

More than one site took part, so the men came from several places.

Primary outcome is difference in AVC score from baseline to follow-up at 2 years.

Intention-to-treat principle is used for all analyses.

What Was Measured

Topics PubMed links to this paper include Aortic Valve, Aortic Valve Stenosis, Calcinosis, Disease Progression, Hemostatics, Randomized Controlled Trials as Topic and Tomography, X-Ray Computed.

Author keywords: aortic valve calcification, cardiovascular imaging, menaquinone-7, randomized clinical trial and valvular heart disease.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Vitamin D, K2, Magnesium and Zinc in 400 men.

With several hundred people or more, it is a fairly large study for this kind of research.

The publication is from 2018 (BMJ open), a journal based in England.

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