SLOW-Slower Progress of caLcificatiOn With Vitamin K2

Plain-language guide to NCT04429035: not phased randomized trial of Vitamin D, K2, Magnesium and Zinc, 200 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT04429035
Phase: not phased
Status: status unknown
Start: 2019-09-23
Completion (planned or actual): 2022-10-23
Participants: 200 (estimated)
Design: randomized, quadruple-blind, treatment
Conditions studied: Aortic Valve Stenosis; Aortic Valve Calcification; Mitral Annular Calcification; Mitral Valve Calcification; Mitral Valve Stenosis
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

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

A randomized 12-month trial will include two groups of 100 individuals aged over 50 years, with asymptomatic mild to moderate Aortic valve stenosis (AVA \> 1 cm2, Vmax \< 4 m/s).

Both groups will be monitored identically in order to investigate therapeutic effects on calcification and valve stenosis progression.

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

Participants receive Vitamin K2 (Menaquinone) placebo tablet matching Vitamin K2 (Menaquinone) orally 3 times daily for 12 months.

The registry classes the interventions as dietary supplement.

Who Took Part

200 planned participants were the target.

It was open to people of any sex aged from 50 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: ASYMPTOMATIC AV STENOSIS WITH AVA\>1 cm2 \& Vmax\<4m/s.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: AVK,STATINS,MSCT THE LAST 6 MONTHS,PROSTHETIC VALVES, AVA\<1 cm2,Vmax\>4m/s.

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.

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 2019-09-23 with completion listed for 2022-10-23.

It ran at 2 sites in Greece (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Evaluation of calcification change of Aortic valve.Correlation With Mitral annulus and ascending Aorta calcification.A randomized 12-month trial.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Vitamin D, K2, Magnesium and Zinc in 200 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.

Our Notes on the Compound

Vitamin D, K2, Magnesium and Zinc: Magnesium is described as required for AMPK to function.

Vitamin D, K2, Magnesium and Zinc in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.