Oslo, Norway and East Brunswick, NJ—NattoPharma announced that a new 1.5-year placebo-controlled, randomized, open-label intervention clinical trial using MenaQ7 Vitamin K2 as MK-7 has been registered on ClinicalTrials.gov, and is scheduled to start in September 2021. The trial, titled The Effect of Vitamin K2 Supplementation on Arterial Stiffness and Cardiovascular Events in PEritonial DIAlysis (VIKIPEDIA), will examine the cardiovascular impact in a patient population.
Details of the study, as outlined in a press release: The trial will be conducted with Peritoneal Dialysis (PD) patients. The investigators at Aristotle University of Thessaloniki in Greece will study the effect of K2 supplementation (through normalization of dp-ucMGP) on arterial stiffness and the occurrence of cardiovascular events, and they will use the highest dosage of K2 as MK-7 to date, at 1-mg daily.
NattoPharma explained in the release that chronic Kidney Disease (CKD) is a state of progressive vascular calcification and cardiovascular disease. End Stage Kidney Disease patients receive renal replacement therapy either by hemodialysis or by PD, according to lead researcher Stefanos Roumeliotis , M.D., Ph.D.
“Several studies have shown that hemodialysis patients have vitamin K depletion and accelerated vascular calcification, and this finding led to the initiation of several randomized controlled trials exploring the effect of vitamin K2 supplementation on vascular calcification in hemodialysis patients,” Dr. Roumeliotis said in the release . “VIKIPEDIA is the first study to assess whether high dosage of Menaquinone-7 could improve arterial stiffness, mortality, cardiovascular disease, 24–hour ambulatory blood pressure and dialysis efficacy in patients with PD. MenaQ7 was chosen to be used in the study because the compound showed its efficacy to improve vitamin K status in many clinical trials with kidney patients.”
A detailed description of the clinical trial, available here, explains that since vitamin D and magnesium are considered to be very important in vitamin K metabolism, after baseline, patients with vitamin D and/or magnesium depletion will be treated with oral supplements to achieve normal levels of both elements, before randomization.
Dr. Hogne Vik, Chief Medical Officer with NattoPharma, noted in the press release that researchers recognized the importance of optimal level of vitamin D and magnesium to support function of vitamin K2, which is why patients deficient in either nutrient will be treated to reach normal levels before randomization.
“People with kidney problems exhibits low vitamin K status, which has been shown to increase cardiovascular disease as well as mortality risk,” explained Dr. Vik. “Vitamin K2 supplementation was shown to be effective to improve vitamin K status in kidney patients to some extent. However, none of these trials have been conducted in PD patients, but only in pre-dialysis CKD or haemodialysis subjects or kidney transplant patients.”
Dr. Vik added: “VIKIPEDIA represents two important firsts: it will be the first trial in PD patients, and the first time this high dosage of vitamin K2 as MK-7 will be used, which supports high safety profile of this nutrient. We are thrilled because this study will add to the already substantial evidence that MenaQ7 Vitamin K2 is an important cardiovascular-support nutrient, and it presents great hope for an at-risk patient population.”