Decalcification of the Aortic Valve by Vitamin K2 (Menaquinone-7)

What Was Tested

This registered phase 2 trial tested Vitamin D, K2, Magnesium and Zinc.

Aortic Stenosis is a common but fatal disease when it becomes symptomatic, specially if not treated.

It had two arms (groups): Interventional (active comparator) and interventional (active comparator).

The registry classes the interventions as dietary supplement.

Who Took Part

Enrollment: 150 planned participants were the target.

It was open to people of any sex aged from 30 years up to 85 years.

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

Examples of who could join: AVCS \> 300 without aortic valve stenosis requiring operation. Focus on patients with:. Bicuspid aortic valve. Dialysis or CKD.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: use of vitamin k antagonist; malabsorption problem; A life expectancy \< 3 years.

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.

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, care provider, investigator and outcomes assessor.

It started in 2018-01-02 with completion listed for 2020-12.

It ran at 1 site in Lebanon.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Evolution of the Aortic Valve Hemodynamic measured by echography: Change in Gradients in (mm Hg) (time frame: 3 years). Evolution of the Aortic Valve Hemodynamic measured by echography: Change in Surface area in (cm2/m2) (time frame: 3 years). Evolution of the Aortic Valve Hemodynamic measured by echography: Change in V max in (m/sec) (time frame: 3 years).

It also tracked 4 secondary outcomes, for example Activation of the MGP measured by the dp-uc MGP level which is a marker of vascular calcification.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Vitamin D, K2, Magnesium and Zinc in 150 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.