학술논문
Effects of vitamins K2 and D3 supplementation in patients with severe coronary artery calcification: a study protocol for a randomised controlled trial.
Document Type
Academic Journal
Author
Hasific S; Department of Cardiology, Odense University Hospital, Odense, Denmark.; Øvrehus KA; Department of Cardiology, Odense University Hospital, Odense, Denmark.; Hosbond S; Department of Cardiology, Sygehus Lillebalt, Vejle, Syddanmark, Denmark.; Lambrechtsen J; Department of Cardiology, Svendborg Hospital, Svendborg, Denmark.; Kumarathurai P; Department of Cardiology, Odense University Hospital, Odense, Denmark.; Mejldal A; Department of Clinical Research, University of Southern Denmark, Odense, Denmark.; Open Patient Data Explorative Network, Odense University, Odense, Denmark.; Ravn EJ; Department of Cardiology, Odense University Hospital, Odense, Denmark.; Rasmussen LM; Department of Clinical Biochemistry and Pharmacology, Odense Universitetshospital, Odense, Denmark.; Centre for Individualised Medicine in Arterial Diseases, Odense Universitetshospital, Odense, Denmark.; Gerke O; Department of Nuclear Medicine, Odense University Hospital, Odense, Denmark.; Mickley H; Department of Cardiology, Odense University Hospital, Odense, Denmark.; Diederichsen A; Department of Cardiology, Odense University Hospital, Odense, Denmark axel.diederichsen@rsyd.dk.
Source
Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE
Subject
Language
English
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.
Competing Interests: Competing interests: None declared.
(© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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.
Competing Interests: Competing interests: None declared.
(© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)