1st Department of Internal Medicine AHEPA Hospital, Medical School, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Department of Nephrology, School of Medicine, Democritus University of Thrace, Alexandroupolis, Greece.
PLoS One. 2022 Aug 17;17(8):e0273102. doi: 10.1371/journal.pone.0273102. eCollection 2022.
Vascular calcification (VC) is an active process, resulting from the disturbance of balance between inhibitors and promoters of calcification, in favor of the latter. Matrix Gla Protein, a powerful inhibitor of VC, needs vitamin K to become active. In vitamin K depletion, plasma levels of the inactive form of MGP, dephosphorylated, uncarboxylated MGP (dp-ucMGP) are increased and associated with VC and cardiovascular (CV) outcomes. End Stage Renal Disease (ESRD) patients have increased circulating dp-ucMGP levels and accelerated VC. VItamin K In PEritoneal DIAlysis (VIKIPEDIA) is a prospective, randomized, open label, placebo-controlled trial, evaluating the effect of vitamin K2 supplementation on arterial stiffness and CV events in ESRD patients undergoing peritoneal dialysis (PD). Forty-four PD patients will be included in the study. At baseline, dp-ucMGP and pulse-wave velocity (PWV) will be assessed and then patients will be randomized (1:1 ratio) to vitamin K (1000 μg MK-7/day) or placebo for 1.5 years. The primary endpoint of this trial is the change in PWV in the placebo group as compared to the treatment group. Secondary endpoints are the occurrence of CV events, mortality, changes in PD adequacy, change in 24-hour ambulatory blood pressure indexes and aortic systolic blood pressure and changes in calcium/phosphorus/parathormone metabolism. VIKIPEDIA is a new superiority randomized, open label, placebo-controlled trial aiming to determine the effect of vitamin K2 supplementation on VC, CV disease and calcium/phosphorus metabolism, in PD patients. Trial registration: The protocol of this study is registered at ClinicalTrials.gov with identification number NCT04900610 (25 May 2021).
血管钙化 (VC) 是一个活跃的过程，是由于钙化抑制剂和促进剂之间的平衡被打破，有利于后者而导致的。基质 Gla 蛋白（MGP）是一种强大的 VC 抑制剂，需要维生素 K 才能发挥作用。在维生素 K 缺乏时，无活性形式的 MGP（去磷酸化、未羧化 MGP，dp-ucMGP）的血浆水平增加，并与 VC 和心血管 (CV) 结局相关。终末期肾脏疾病 (ESRD) 患者的循环 dp-ucMGP 水平升高，且 VC 进展加速。VItamin K In PEritoneal DIAlysis (VIKIPEDIA) 是一项前瞻性、随机、开放标签、安慰剂对照试验，评估了维生素 K2 补充对腹膜透析 (PD) 患者动脉僵硬和 CV 事件的影响。该研究将纳入 44 名 PD 患者。在基线时，将评估 dp-ucMGP 和脉搏波速度 (PWV)，然后将患者以 1:1 的比例随机分为维生素 K（MK-7 每天 1000μg）或安慰剂组，进行为期 1.5 年的治疗。该试验的主要终点是安慰剂组与治疗组之间 PWV 的变化。次要终点是 CV 事件、死亡率、PD 充分性的变化、24 小时动态血压指标和主动脉收缩压的变化以及钙/磷/甲状旁腺激素代谢的变化。VIKIPEDIA 是一项新的优势随机、开放标签、安慰剂对照试验，旨在确定维生素 K2 补充对 PD 患者 VC、CV 疾病和钙/磷代谢的影响。试验注册：该研究的方案在 ClinicalTrials.gov 上注册，识别号为 NCT04900610（2021 年 5 月 25 日）。
