An interventional study of MenaQ7 ®, Nattopharma, ASA, Hovik, Norway in Vitamin K Deficiency, End Stage Renal Disease and Peritoneal Dialysis, sponsored by Aristotle University Of Thessaloniki. Status unknown. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-05-25.
Sponsored by Aristotle University Of Thessaloniki · Not applicable, Interventional, and Treatment
VIKIPEDIA is a multi-centre, placebo-controlled, randomized, open-label intervention clinical trial on Peritoneal Dialysis (PD) patients. At baseline the investigators will recruit End-Stage Renal Disease patients undergoing PD and randomize them to either daily per os supplementation of 1mg menaquinone-7 or placebo for 1.5 year. The investigators will study the effect of vitamin K2 supplementation (through normalization of dp-ucMGP) on arterial stifness and the occurence of cardiovascular events. The investigators will also cosider as secondary endpoints, mortality, central aortic blood pressure and indices of 24h-ambulatory blood pressure.
VIKIPEDIA is a multi-centre, placebo-controlled, randomized, open-label intervention clinical trial on PD patients. The study protocol was developed in accordance with the Helsinki Declaration of Human Rights and the Good Clinical Practice Guidelines and Standard Protocol Items: Recommendations for Intervention Trials, was approved by the Ethics Committee/Scientific Council of the Medical School of Aristotle University of Thessaloniki (235/14.05.2021) All participants will provide a structured, written, informed consent. Three university, tertiary hospitals in Northern Greece with major, referral PD units will participate in the study. The patients will be recruited within 1 year. At baseline, all eligible patients who have provided 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 randomization, the investigators will draw blood (serum and plasma) and PD fluid samples from all patients to measure blood count and routine biochemical parameters, including urea, creatinine, potassium, sodium, calcium, phosphorus, c-reactive protein, alkaline phosphatase, albumin, parathormone, 25-OH D3, magnesium, glycated hemoglobin, thyroid function hormones. Since both vitamin D and magnesium are considered of utmost importance 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. The cohort will then be categorized 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 randomization, all patients will continue their routine, standard medical treatment and patients in the treatment group will additionally receive daily, per os 1 mg of vitamin K2 (MenaQ7 ®, Nattopharma, ASA, Hovik, Norway).
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This study's planned enrollment of 120 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
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Exclusion Criteria:
1mg/day per os
Dietary Supplement: MenaQ7 ®, Nattopharma, ASA, Hovik, Norway
matching placebo
Dietary Supplement: MenaQ7 ®, Nattopharma, ASA, Hovik, Norway
daily per os supplementation of 1mg MK-7
Progression of arterial stifness
Change in pulse wave velocity
Time frame: 1.5 years
Non fatal cardiovascular events
Number of patients presenting acute myocardial infarction, acute coronary syndrome, embolism, peripheral arterial disease and stroke
Time frame: 1.5 years
Mortality
Number of participants who willl die from any cause
Time frame: 1.5 years
PD adequacy
Number of patients with preserved residual renal function
Time frame: 1.5 years
PD clearance
Change in Kt/V
Time frame: 1.5 years
Infections/peritonitis
Rate of infections and peritonitis
Time frame: 1.5 years
Parathormone homeostasis
Changes in serum parathormone
Time frame: 1.5 year
Calcium phosphorus homeostasis
Changes in the calcium phosphorus product
Time frame: 1.5 year
Fractures
Incidence of fractures
Time frame: 1.5 years
Joint/muscle pain
Incidence of pain in muscles and/or joints
Time frame: 1.5 years
24-hour ambulatory BP/aortic systolic BP
Change in indices of ambulatory BP and aortic systolic blood pressure
Time frame: 1.5 years
No study locations are listed for this record.
Plan to share: No
This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Aristotle University Of Thessaloniki