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The Effect of Vitamin K2 Supplementation on Arterial Stifness and Cardiovascular Events in PEritonial DIAlysis

NCT04900610 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-05-25

No results posted yet for this study

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.

Conditions

  • Vitamin K Deficiency
  • End Stage Renal Disease
  • Peritoneal Dialysis
  • Arterial Stiffness
  • Cardiovascular Morbidity
  • Mortality

Interventions

DIETARY_SUPPLEMENT

MenaQ7 ®, Nattopharma, ASA, Hovik, Norway

daily per os supplementation of 1mg MK-7

Sponsors & Collaborators

  • Nattopharma ASA

    collaborator INDUSTRY

  • Aristotle University Of Thessaloniki

    lead OTHER

Principal Investigators

  • Stefanos Roumeliotis, MD, PhD · 1st Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki

  • Vassilios Liakopoulos, Professor · 1st Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2022-06-30
Completion
2022-09-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04900610 on ClinicalTrials.gov