Six months vitamin K treatment does not affect systemic arterial calcification or bone mineral density in diabetes melli
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ORIGINAL CONTRIBUTION
Six months vitamin K treatment does not affect systemic arterial calcification or bone mineral density in diabetes mellitus 2 Jonas W. Bartstra1 · Fieke Draaisma1 · Sabine R. Zwakenberg2 · Nikolas Lessmann3 · Jelmer M. Wolterink4 · Yvonne T. van der Schouw2 · Pim A. de Jong1 · Joline W. J. Beulens5 Received: 30 June 2020 / Accepted: 6 October 2020 © The Author(s) 2020
Abstract Purpose Vitamin K-dependent proteins are involved in (patho)physiological calcification of the vasculature and the bones. Type 2 diabetes mellitus (DM2) is associated with increased arterial calcification and increased fractures. This study investigates the effect of 6 months vitamin K2 supplementation on systemic arterial calcification and bone mineral density (BMD) in DM2 patients with a history of cardiovascular disease (CVD). Methods In this pre-specified, post hoc analysis of a double-blind, randomized, controlled clinical trial, patients with DM2 and CVD were randomized to a daily, oral dose of 360 µg vitamin K2 or placebo for 6 months. CT scans were made at baseline and follow-up. Arterial calcification mass was quantified in several large arterial beds and a total arterial calcification mass score was calculated. BMD was assessed in all non-fractured thoracic and lumbar vertebrae. Results 68 participants were randomized, 35 to vitamin K2 (33 completed follow-up) and 33 to placebo (27 completed follow-up). The vitamin K group had higher arterial calcification mass at baseline [median (IQR): 1694 (812–3584) vs 1182 (235–2445)] for the total arterial calcification mass). Six months vitamin K supplementation did not reduce arterial calcification progression (β [95% CI]: − 0.02 [− 0.10; 0.06] for the total arterial calcification mass) or slow BMD decline (β [95% CI]: − 2.06 [− 11.26; 7.30] Hounsfield units for all vertebrae) when compared to placebo. Conclusion Six months vitamin K supplementation did not halt progression of arterial calcification or decline of BMD in patients with DM2 and CVD. Future clinical trials may want to pre-select patients with very low vitamin K status and longer follow-up time might be warranted. This trial was registered at clinicaltrials.gov as NCT02839044 Keywords Randomized controlled clinical trial · Type 2 diabetes · Cardiovascular disease · Vitamin K · Arterial calcification · Bone mineral density
* Joline W. J. Beulens [email protected] 1
Department of Radiology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands
2
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands
3
Diagnostic Image Analysis Group, Department of Radiology and Nuclear Medicine, Radboudumc, Nijmegen, The Netherlands
4
Department of Applied Mathematics, Technical Medical Centre, University of Twente, Enschede, The Netherlands
5
Department of Epidemiology and Data Science, Amsterdam University Medical Centers, Location VUmc, Amsterdam Public Health and Amsterdam Cardiovascular Sci
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