Randomized Controlled Clinical Trial to Investigate Effects of Vitamin K2 in COVID-19

What Was Tested

The trial (not phased) is built around Vitamin D, K2, Magnesium and Zinc.

Coronavirus disease 2019 (COVID-19) is caused by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2).

While the majority of people recover after mild symptoms, a portion of COVID-19 patients develops respiratory failure.

It had two arms (groups): Experimental: Vitamin K2 (active comparator) and Control: Placebo (placebo comparator).

Patients with COVID-19 who get placebo as control, three tablets a day, for 14 days or until discharge, whichever occurs earlier.

The registry classes the interventions as dietary supplement.

More on the Plan

The outbreak of coronavirus 2019 disease (COVID-19) has a major impact on health care worldwide.

This infectious disease is caused by the severe acute respiratory syndrome coronavirus (SARS-CoV-2).

The pathogenesis of this coagulopathy, and the links between pulmonary and thromboembolic manifestations of COVID-19 are incompletely understood.

In KOVIT trial, the roll of vitamin K in the pathogenesis of these manifestations will be elucidated.

Who Took Part

40 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: COVID-19 patients who are admitted to the CWZ with COVID-19, with a laboratory confirmed SARS-CoV-2 infection within the previous 96 hours. At least 18 years old. Informed consent signed by patient.

The full record lists 6 inclusion and 10 exclusion criteria; among the exclusions: use of oral anticoagulation drugs; patients may be included when they have been switched to lmwh; patients already using vitamin k supplements at admission; participation in another intervention study.

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 2021-02-22 with completion listed for 2022-03-01.

It ran at 1 site in Netherlands.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Plasma desmosine levels (time frame: Day 1 until day 28 or until discharge if this is earlier). Plasma dp-ucMGP levels (time frame: Day 1 until day 28 or until discharge if this is earlier).

It also tracked 2 secondary outcomes, for example Difference between the number of grade 3 and grade 4 adverse events and Serum PIVKA-II levels.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Vitamin D, K2, Magnesium and Zinc in 40 people.

The trial is marked completed; 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.