The ViKTORIES trial: a randomised, double-blind, placebo-controlled trial of vitamin K supplementation to improve vascular health in kidney transplant recipients

Lees, J. S. et al. (2021) The ViKTORIES trial: a randomised, double-blind, placebo-controlled trial of vitamin K supplementation to improve vascular health in kidney transplant recipients. American Journal of Transplantation, 21(10), pp. 3356-3368. (doi: 10.1111/ajt.16566) (PMID:33742520)

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Abstract

Premature cardiovascular disease and death with a functioning graft are leading causes of death and graft loss respectively in kidney transplant recipients (KTR). Vascular stiffness and calcification are markers of cardiovascular disease that are prevalent in KTR and associated with subclinical vitamin K deficiency. We performed a single‐centre, phase II, parallel‐group, randomised, double‐blind, placebo‐controlled trial (ISRCTN22012044) to test whether vitamin K supplementation reduced vascular stiffness (MRI‐based aortic distensibility) or calcification (coronary artery calcium score on computed tomography) in KTR over 1 year of treatment. The primary outcome was between‐group difference in vascular stiffness (ascending aortic distensibility). KTR were recruited between September 2017 and June 2018, and randomised 1:1 to vitamin K (Menadiol diphosphate 5mg; n=45) or placebo (n=45) thrice‐weekly. Baseline demographics, clinical history and immunosuppression regimens were similar between groups. There was no impact of vitamin K on vascular stiffness (treatment effect ‐0.23 (95% CI ‐0.75 to 0.29) x10‐3 mmHg‐1; p=0.377), vascular calcification (treatment effect ‐141 (95% CI ‐320 to 38) units; p=0.124), nor any other outcome measure. In this heterogeneous cohort of prevalent KTR, vitamin K supplementation did not reduce vascular stiffness or calcification over 1 year. Improving vascular health in KTR is likely to require a multifaceted approach.

Item Type:Articles
Additional Information:We would like to thank the kidney research nurses, clinical trials pharmacy and ViKTORIES participants. ViKTORIES was an investigator-led clinical trial that was funded by Kidney Research UK (TF_013_20161225) and Darlinda’s Charity for Renal Research. J.S.L. was personally funded by a Kidney Research UK Training Fellowship (TF_013_20161225) and a British Heart Foundation Centre of Excellence Award (RE/13/5/30177). J.S.L. and E.R. are currently funded by Chief Scientist Office (Scotland) Postdoctoral Lectureships. M.D.W. acknowledges support from the NIHR Newcastle Biomedical Research Centre.
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Rutherford, Dr Elaine and Mangion, Dr Kenneth and Lees, Jennifer and Roditi, Dr Giles and Mark, Professor Patrick and Gillis, Dr Keith and Rankin, Dr Alastair and Jardine, Professor Alan
Authors: Lees, J. S., Rankin, A. J., Gillis, K. A., Zhu, L. Y., Mangion, K., Rutherford, E., Roditi, G. H., Witham, M. D., Chantler, D., Panarelli, M., Jardine, A. G., and Mark, P. B.
College/School:College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health
Journal Name:American Journal of Transplantation
Publisher:Wiley
ISSN:1600-6135
ISSN (Online):1600-6143
Published Online:19 March 2021
Copyright Holders:Copyright © 2021 The Authors
First Published:First published in American Journal of Transplantation 21(10): 3356-4468
Publisher Policy:Reproduced under a Creative Commons License

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Project CodeAward NoProject NamePrincipal InvestigatorFunder's NameFunder RefLead Dept
190814BHF centre of excellenceRhian TouyzBritish Heart Foundation (BHF)RE/13/5/30177Institute of Cardiovascular & Medical Sciences