Status:
UNKNOWN
The Effect of Vitamin K2 Supplementation on Arterial Stifness and Cardiovascular Events in PEritonial DIAlysis
Lead Sponsor:
Aristotle University Of Thessaloniki
Collaborating Sponsors:
Nattopharma ASA
Conditions:
Vitamin K Deficiency
End Stage Renal Disease
Eligibility:
All Genders
18-90 years
Phase:
NA
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 Dis...
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 Huma...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- At least 3 months on PD
- Life expectancy of ≥ 18 months
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04900610
Start Date
September 1 2021
End Date
September 1 2022
Last Update
May 25 2021
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