The Effects of Vitamin K2 Supplementation on the Progression of Coronary Artery Calcification

What Was Tested

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

Both Coronary Artery Calcification (CAC)and its annual progression are a strong predictors of cardiovascular events.

The development of arterial calcification results from imbalance between calcification promoting and inhibiting factors.

An important inhibitor of calcification is Matrix Gla Protein (MGP): a protein present in the vascular wall where it is synthesized by Vascular Smooth Muscle Cells (VSMC).

It had two arms (groups): Vitamin K2 supplementation (experimental) and Placebo control (placebo comparator).

The registry classes the interventions as dietary supplement and other.

Who Took Part

180 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Age 18 years or older. Baseline Coronary Computed Tomographic Angiography (CCTA) of sufficient quality. Baseline Agatston calciumscore 100 - 400.

The full record lists 3 inclusion and 11 exclusion criteria; among the exclusions: baseline-scan of insufficient quality; heart rate greater than 70 beats per minute during first scan.(despite adequate treatment with metoprolol); chronic or paroxysmal atrial fibrillation.

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.

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

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

It started in 2011-10 with completion listed for 2019-10.

It ran at 1 site in Netherlands.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Coronary Artery Calcification-score progression (time frame: 12 and 24 months).

It also tracked 2 secondary outcomes, for example Arterial Stiffness measured by Carotid-Femoral Pulse-Wave Velocity and Carotid Intima Media Thickness.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Vitamin D, K2, Magnesium and Zinc in 180 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.