Study protocol of the InterVitaminK trial: a Danish population-based randomised double-blinded placebo-controlled trial of the effects of vitamin K (menaquinone-7) supplementation on cardiovascular, metabolic and bone health.

Autor:	Kampmann FB; Center for Clinical Research and Prevention, Copenhagen University Hospital - Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark., Thysen SM; Center for Clinical Research and Prevention, Copenhagen University Hospital - Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark., Nielsen CFB; Center for Clinical Research and Prevention, Copenhagen University Hospital - Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark., Kofoed KF; Department of Cardiology and Radiology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.; Department of Clinical Medicine, University of Copenhagen Faculty of Health and Medical Sciences, Copenhagen, Denmark., Køber L; Department of Cardiology and Radiology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark., Pham MHC; Department of Cardiology and Radiology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark., Vaag A; Steno Diabetes Center Copenhagen, Copenhagen University Hospital, Herlev, Denmark.; Department of Clinical Sciences, Lund University Diabetes Center, Malmö, Sweden.; Department of Endocrinology, Skåne University Hospital, Malmö, Sweden., Jørgensen NR; Department of Clinical Medicine, University of Copenhagen Faculty of Health and Medical Sciences, Copenhagen, Denmark.; Department of Clinical Biochemistry, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark., Petersen J; Center for Clinical Research and Prevention, Copenhagen University Hospital - Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.; Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark., Jacobsen RK; Center for Clinical Research and Prevention, Copenhagen University Hospital - Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark., Kårhus LL; Center for Clinical Research and Prevention, Copenhagen University Hospital - Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark., Diederichsen A; Department of Cardiology, Odense University Hospital, Odense, Denmark.; Elitary Research Centre of Individualized Medicine in Arterial Disease (CIMA), Odense University Hospital, Odense, Denmark., Frimodt-Møller M; Steno Diabetes Center Copenhagen, Copenhagen University Hospital, Herlev, Denmark., Linneberg A; Center for Clinical Research and Prevention, Copenhagen University Hospital - Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark allan.linneberg@regionh.dk.; Department of Clinical Medicine, University of Copenhagen Faculty of Health and Medical Sciences, Copenhagen, Denmark.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2023 May 19; Vol. 13 (5), pp. e071885. Date of Electronic Publication: 2023 May 19.
DOI:	10.1136/bmjopen-2023-071885
Abstrakt:	Introduction: Vitamin K has been suggested to have protective effects against progression of vascular calcification and development of cardiovascular disease (CVD). However, few well-powered randomised controlled trials have examined whether vitamin K prevents progression of vascular calcification in individuals from the general population. The aim of the InterVitaminK trial is to investigate the effects of vitamin K supplementation (menaquinone-7, MK-7) on cardiovascular, metabolic, respiratory and bone health in a general ageing population with detectable vascular calcification. Methods and Analysis: The InterVitaminK trial is a randomised, double-blinded, placebo-controlled, trial. A total of 450 men and women aged 52-82 years with detectable coronary artery calcification (CAC), but without manifest CVD, will be randomised (1:1) to receive daily MK-7 (333 µg/day) or placebo tablets for 3 years. Health examinations are scheduled at baseline, and after 1, 2 and 3 years of intervention. Health examinations include cardiac CT scans, measurements of arterial stiffness, blood pressure, lung function, physical function, muscle strength, anthropometric measures, questionnaires on general health and dietary intake, and blood and urine sampling. The primary outcome is progression of CAC from baseline to 3-year follow-up. The trial has 89% power to detect a between-group difference of at least 15%. Secondary outcomes are bone mineral density, pulmonary function and biomarkers of insulin resistance. Ethics and Dissemination: Oral MK-7 supplementation is considered safe and has not been found to cause severe adverse events. The Ethical Committee of the Capital Region (H-21033114) approved the protocol. Written informed consent is obtained from all participants and the trial is conducted in accordance with the Declaration of Helsinki II. Both negative and positive findings will be reported. Trial Registration Number: NCT05259046. Competing Interests: Competing interests: FBK, SMT and AL have received funds and tablets for the trial from Kappa Bioscience AS. AL discloses the application of a patent on vitamin K on lung function for prognostic and therapeutic purposes. Aside from this, the authors declare no conflicts of interest. (© 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.)
Databáze:	MEDLINE
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