Bicuspid Aortic Valve Stenosis and the Effect of vItamin K2 on Calciummetabolism on 18F-NaF PET/MRI

What Was Tested

In this phase 2 trial, researchers set out to test Vitamin D, K2, Magnesium and Zinc.

Early development of calcified aortic valve disease (CAVD) is a commonly occurring complication in patients with a bicuspid aortic valve (BAV, an aortic valve consisting of two leaflets instead of three).

In general, CAVD is characterized by progressive narrowing of the aortic valve, with involvement of altered calcium metabolism.

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

22 patients will receive placebo during 18 months.

The registry classes the interventions as dietary supplement and other.

Who Took Part

The registry lists 44 planned participants were the target.

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: Known bicuspid aortic valve. Calcified mild to moderate aortic valve stenosis on prior echocardiography. Informed consent provided.

The full record lists 3 inclusion and 11 exclusion criteria; among the exclusions: absence of calcified aortic valve stenosis on echocardiography; presence of severe aortic valve stenosis; history of aortic valve repair or replacement.

How the Study Was Run

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

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.

The Vitamin D, K2, Magnesium and Zinc group and the comparison group ran side by side rather than switching.

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 2016-08 with completion listed for 2019-12.

It ran at 1 site in Netherlands.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in aortic valve calcium metabolism (time frame: Measured at baseline and 6 months).

It also tracked 2 secondary outcomes, for example Change in aortic valve calcium score and Progression of aortic valve stenosis.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Vitamin D, K2, Magnesium and Zinc in 44 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.