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The DANish COronary DEcalcification (DANCODE) Trial

Plain-language guide to NCT05500443: not phased randomized trial of Vitamin D, K2, Magnesium and Zinc, 400 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05500443
Phase
not phased
Status
completed
Start
2023-02-08
Completion (planned or actual)
2026-07-04
Participants
400 (actual)
Design
randomized, quadruple-blind, prevention
Conditions studied
Coronary Artery Disease
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Vitamin D, K2, Magnesium and Zinc.

Abstract Introduction Coronary artery calcification (CAC) and especially progression in CAC is a strong predictor of acute myocardial infarction and cardiovascular mortality.

This finding should be interpreted with caution, but the perspective is very interesting.

It had two arms (groups): Active treatment (experimental) and Placebo (placebo comparator).

Tablets with placebo.

The registry classes the interventions as dietary supplement.

More on the Plan

Ischaemic heart disease is often silent until symptoms of myocardial infarction.

However, subclinical coronary artery disease is easily detected by non-contrast cardiac CT scans as coronary artery calcifications (CAC).

Vitamin K and the calcification process Vascular calcification is a slowly progressive process and caused by an imbalance between the mechanisms that promote and inhibit the deposition of calcium in the vessel wall, and vitamin K-dependent proteins play an essential role in this inhibition.

The most familiar K vitamin is phylloquinone (vitamin K1), as it is essential in activation of several coagulation factors.

Who Took Part

400 actual participants took part.

It was open to people of any sex.

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

The full record lists 0 inclusion and 7 exclusion criteria; among the exclusions: history of myocardial infarction or coronary revascularization; history of venous thrombosis including pulmonary embolism; coagulation disorders.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Vitamin D, K2, Magnesium and Zinc and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2023-02-08 with completion listed for 2026-07-04.

It ran at 3 sites in Denmark (3).

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Coronary artery calcium (CAC) score, all participants (time frame: From baseline to 24-months follow-up).

It also tracked 7 secondary outcomes, for example CAC score, men only, CAC score, women only, CAC score below 1000 at baseline, all, CAC score above 1000 at baseline, all, Coronary plaque burden and Cardiac events.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Vitamin D, K2, Magnesium and Zinc in 400 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.

Our Notes on the Compound

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

Related Pages

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.