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other·cardiology, clinical nutrition, vitamins, clinical trial, micronutrients·PMC10351276

Effects of vitamins K2 and D3 supplementation in patients with severe coronary artery calcification: a study protocol for a randomised controlled trial

BMJ Open · 11 authors, 8 centres

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TL;DR

This is a protocol for a randomised controlled trial (RCT) investigating whether vitamin K2 and D3 supplementation can slow the progression of coronary artery calcification (CAC) in high-risk patients. The trial will randomise 400 patients with severe CAC to the supplement or placebo for 2 years.

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The paper describes the protocol for the DANCODE trial, a multicentre, double-blinded, placebo-controlled RCT. The analysis will use an intention-to-treat principle. The study is expected to report results in 2026.

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other

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cardiology

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ORIGINAL PAPER

PMC10351276

Effects of vitamins K2 and D3 supplementation in patients with severe coronary artery calcification: a study protocol for a randomised controlled trial

BMJ Open

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ABSTRACT

Abstract Introduction Coronary artery calcification (CAC) and especially progression in CAC is a strong predictor of acute myocardial infarction and cardiovascular mortality. Supplementation with vitamin K2 and D3 has been suggested to have a protective role in the progression of CAC. In this study, we will examine the effect of vitamins K2 and D3 in men and women with severe CAC. We hypothesise that supplementation with vitamins K2 and D3 will slow down the calcification process. Method and analysis In this multicentre and double-blinded placebo-controlled study, 400 men and women with CAC score≥400 are randomised (1:1) to treatment with vitamin K2 (720 µg/day) and vitamin D3 (25 µg/day) or placebo treatment (no active treatment) for 2 years. Among exclusion criteria are treatment with vitamin K antagonist, coagulation disorders and prior coronary artery disease. To evaluate progression in coronary plaque, a cardiac CT-scan is performed at baseline and repeated after 12 and 24 months of follow-up. Primary outcome is progression in CAC score from baseline to follow-up at 2 years. Among secondary outcomes are coronary plaque composition and cardiac events. Intention-to-treat principle is used for all analyses. Ethics and dissemination There are so far no reported adverse effects associated with the use of vitamin K2. The protocol was approved by the Regional Scientific Ethical Committee for Southern Denmark and the Data Protection Agency. It will be conducted in accordance with the Declaration of Helsinki. Positive as well as negative findings will be reported. Trial registration number NCT05500443 . Keywords: Ischaemic heart disease, Clinical Trial, NUTRITION & DIETETICS, PREVENTIVE MEDICINE, Cardiovascular imaging

CITATION EXPORT

Selma Hasific, Kristian A Øvrehus, Susanne Hosbond et al.. Effects of vitamins K2 and D3 supplementation in patients with severe coronary artery calcification: a study protocol for a randomised controlled trial. BMJ Open. (2023). https://doi.org/10.1136/bmjopen-2023-073233

AUTHORS

11 · 8 CENTRES

Selma Hasific, Kristian A Øvrehus, Susanne Hosbond, Jess Lambrechtsen, Preman Kumarathurai, Anna Mejldal, Emil Johannes Ravn, Lars Melholt Rasmussen, Oke Gerke, Hans Mickley, Axel Diederichsen

1Department of Cardiology, Odense University Hospital, Odense, Denmark
2Department of Cardiology, Sygehus Lillebalt, Vejle, Syddanmark, Denmark
3Department of Cardiology, Svendborg Hospital, Svendborg, Denmark
4Department of Clinical Research, University of Southern Denmark, Odense, Denmark
5Open Patient Data Explorative Network, Odense University, Odense, Denmark
6Department of Clinical Biochemistry and Pharmacology, Odense Universitetshospital, Odense, Denmark
7Centre for Individualised Medicine in Arterial Diseases, Odense Universitetshospital, Odense, Denmark
8Department of Nuclear Medicine, Odense University Hospital, Odense, Denmark