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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04900610
Other study ID # 235/14.05.2021
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2021
Est. completion date September 2022

Study information

Verified date May 2021
Source Aristotle University Of Thessaloniki
Contact Stefanos Roumeliotis, MD, PhD
Phone +302313303110
Email st_roumeliotis@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date September 2022
Est. primary completion date June 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Age = 18 years - At least 3 months on PD - Life expectancy of = 18 months Exclusion Criteria: - Liver disease - Drug or alcohol abuse - Pregnancy or breast-feeding - Treatment with phosphate binders (sevelamer) - Ongoing malignancy or severe inflammatory disease diagnosis - Use of vitamin K antagonist or vitamin K supplements during the past 3 months - Diagnosis of severe gut-disease (inflammatory or short bowel disease) or gastrointestinal malabsorption - Mental disorder rendering the patient unable to conform with the instructions and fully understand the nature, aim and possible side-effects of the supplementation

Study Design


Intervention

Dietary Supplement:
MenaQ7 ®, Nattopharma, ASA, Hovik, Norway
daily per os supplementation of 1mg MK-7

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Aristotle University Of Thessaloniki Nattopharma ASA

References & Publications (7)

Haroon SW, Tai BC, Ling LH, Teo L, Davenport A, Schurgers L, Teo BW, Khatri P, Ong CC, Low S, Yeo XE, Tan JN, Subramanian S, Chua HR, Tan SY, Wong WK, Lau TW. Treatment to reduce vascular calcification in hemodialysis patients using vitamin K (Trevasc-HDK — View Citation

Peeters FECM, van Mourik MJW, Meex SJR, Bucerius J, Schalla SM, Gerretsen SC, Mihl C, Dweck MR, Schurgers LJ, Wildberger JE, Crijns HJGM, Kietselaer BLJH. Bicuspid Aortic Valve Stenosis and the Effect of Vitamin K2 on Calcification Using (18)F-Sodium Fluo — View Citation

Roumeliotis S, Dounousi E, Eleftheriadis T, Liakopoulos V. Association of the Inactive Circulating Matrix Gla Protein with Vitamin K Intake, Calcification, Mortality, and Cardiovascular Disease: A Review. Int J Mol Sci. 2019 Feb 1;20(3). pii: E628. doi: 1 — View Citation

Roumeliotis S, Dounousi E, Salmas M, Eleftheriadis T, Liakopoulos V. Vascular Calcification in Chronic Kidney Disease: The Role of Vitamin K- Dependent Matrix Gla Protein. Front Med (Lausanne). 2020 Apr 24;7:154. doi: 10.3389/fmed.2020.00154. eCollection — View Citation

Roumeliotis S, Roumeliotis A, Dounousi E, Eleftheriadis T, Liakopoulos V. Vitamin K for the Treatment of Cardiovascular Disease in End-Stage Renal Disease Patients: Is there Hope? Curr Vasc Pharmacol. 2021;19(1):77-90. doi: 10.2174/15701611186662003201117 — View Citation

Vaios V, Georgianos PI, Vareta G, Dounousi E, Dimitriadis C, Eleftheriadis T, Papagianni A, Zebekakis PE, Liakopoulos V. Clinic and Home Blood Pressure Monitoring for the Detection of Ambulatory Hypertension Among Patients on Peritoneal Dialysis. Hyperten — View Citation

Xu Q, Guo H, Cao S, Zhou Q, Chen J, Su M, Chen S, Jiang S, Shi X, Wen Y. Associations of vitamin K status with mortality and cardiovascular events in peritoneal dialysis patients. Int Urol Nephrol. 2019 Mar;51(3):527-534. doi: 10.1007/s11255-019-02080-x. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Progression of arterial stifness Change in pulse wave velocity 1.5 years
Primary Non fatal cardiovascular events Number of patients presenting acute myocardial infarction, acute coronary syndrome, embolism, peripheral arterial disease and stroke 1.5 years
Secondary Mortality Number of participants who willl die from any cause 1.5 years
Secondary PD adequacy Number of patients with preserved residual renal function 1.5 years
Secondary PD clearance Change in Kt/V 1.5 years
Secondary Infections/peritonitis Rate of infections and peritonitis 1.5 years
Secondary Parathormone homeostasis Changes in serum parathormone 1.5 year
Secondary Calcium phosphorus homeostasis Changes in the calcium phosphorus product 1.5 year
Secondary Fractures Incidence of fractures 1.5 years
Secondary Joint/muscle pain Incidence of pain in muscles and/or joints 1.5 years
Secondary 24-hour ambulatory BP/aortic systolic BP Change in indices of ambulatory BP and aortic systolic blood pressure 1.5 years
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