The multi-centre, placebo-controlled, randomised, open-label intervention clinical trial will be done with peritoneal dialysis (PD) patients
A 1.5-year clinical trial using NattoPharma’s MenaQ7 Vitamin K2 as MK-7 has been registered on ClinicalTrials.gov. The trial will examine the cardiovascular impact in a patient population and will use the highest dosage of K2 as MK-7 to date: 1 mg daily.
The multi-centre, placebo-controlled, randomised, open-label intervention clinical trial will be done with peritoneal dialysis (PD) patients. The investigators at Aristotle University of Thessaloniki in Greece will study the effect of K2 supplementation (through normalisation of dp-ucMGP) on arterial stiffness and the occurrence of cardiovascular events.
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 , PhD. He said: “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.
“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.”
All eligible patients who provide a written, informed consent will be enrolled in the study. Αortic stiffness and vitamin K status will be assessed by PWV and plasma dp-ucMGP levels respectively. Before randomisation, the investigators will draw blood (serum and plasma) and PD fluid samples from all patients to measure blood count and routine biochemical parameters.
Since both vitamin D and magnesium are important to 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. The cohort will then be categorised to one of the two groups (placebo or active group) and the treatment period will last 1.5 years. To ensure that the two parallel groups will include patients that will not differ significantly in vitamin K and stiffness, patients will be accordingly stratified. After randomisation, all patients will continue standard medical treatment and patients in the treatment group will also receive 1 mg of vitamin K2 daily.
According to Dr Hogne Vik, CMO with NattoPharma, the researchers recognise the importance of optimal level of vitamin D and magnesium to support function of vitamin K2, which is why patients deficient in either will be treated with the nutrients to reach normal levels before randomisation.
“People with kidney problems exhibit low vitamin K status, which has been shown to increase cardiovascular disease as well as mortality risk,” said 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.
“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,” added Vik.
The study is scheduled to start in September 2021. The researchers will collaborate with NattoPharma research partner Masstricht University to evaluate vitamin K status.