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Trial record 1 of 1 for:    peritoneal | vitamin k
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The Effect of Vitamin K2 Supplementation on Arterial Stifness and Cardiovascular Events in PEritonial DIAlysis (VIKIPEDIA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04900610
Recruitment Status : Unknown
Verified May 2021 by Vaios Vasileios, Aristotle University Of Thessaloniki.
Recruitment status was:  Not yet recruiting
First Posted : May 25, 2021
Last Update Posted : May 25, 2021
Nattopharma ASA
Information provided by (Responsible Party):
Vaios Vasileios, Aristotle University Of Thessaloniki

Brief 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.

Condition or disease Intervention/treatment Phase
Vitamin K Deficiency End Stage Renal Disease Peritoneal Dialysis Arterial Stiffness Cardiovascular Morbidity Mortality Dietary Supplement: MenaQ7 ®, Nattopharma, ASA, Hovik, Norway Not Applicable

Detailed 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multi-centre, placebo-controlled, randomized, open-label intervention clinical trial
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Vitamin K In PEritonial DIAlysis (VIKIPEDIA)
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Vitamin K
Drug Information available for: Menadione

Arm Intervention/treatment
Active Comparator: Vitamin K2
1mg/day per os
Dietary Supplement: MenaQ7 ®, Nattopharma, ASA, Hovik, Norway
daily per os supplementation of 1mg MK-7

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

Primary Outcome Measures :
  1. Progression of arterial stifness [ Time Frame: 1.5 years ]
    Change in pulse wave velocity

  2. Non fatal cardiovascular events [ Time Frame: 1.5 years ]
    Number of patients presenting acute myocardial infarction, acute coronary syndrome, embolism, peripheral arterial disease and stroke

Secondary Outcome Measures :
  1. Mortality [ Time Frame: 1.5 years ]
    Number of participants who willl die from any cause

  2. PD adequacy [ Time Frame: 1.5 years ]
    Number of patients with preserved residual renal function

  3. PD clearance [ Time Frame: 1.5 years ]
    Change in Kt/V

  4. Infections/peritonitis [ Time Frame: 1.5 years ]
    Rate of infections and peritonitis

  5. Parathormone homeostasis [ Time Frame: 1.5 year ]
    Changes in serum parathormone

  6. Calcium phosphorus homeostasis [ Time Frame: 1.5 year ]
    Changes in the calcium phosphorus product

  7. Fractures [ Time Frame: 1.5 years ]
    Incidence of fractures

  8. Joint/muscle pain [ Time Frame: 1.5 years ]
    Incidence of pain in muscles and/or joints

  9. 24-hour ambulatory BP/aortic systolic BP [ Time Frame: 1.5 years ]
    Change in indices of ambulatory BP and aortic systolic blood pressure

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04900610

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Contact: Stefanos Roumeliotis, MD, PhD +302313303110 st_roumeliotis@hotmail.com
Contact: Vassilios Liakopoulos, Professor +302313303110 liakopul@otenet.gr

Sponsors and Collaborators
Aristotle University Of Thessaloniki
Nattopharma ASA
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Principal Investigator: Stefanos Roumeliotis, MD, PhD 1st Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki
Principal Investigator: Vassilios Liakopoulos, Professor 1st Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vaios Vasileios, Principal Investigator, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT04900610    
Other Study ID Numbers: 235/14.05.2021
First Posted: May 25, 2021    Key Record Dates
Last Update Posted: May 25, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vaios Vasileios, Aristotle University Of Thessaloniki:
Vitamin K
Peritoneal dialysis
Arterial stifness
Chronic Kidney Disease
End Stage Renal Disease
Additional relevant MeSH terms:
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Vitamin K Deficiency
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Chronic Disease
Disease Attributes
Pathologic Processes
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhagic Disorders
Deficiency Diseases
Nutrition Disorders