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

NCT04900610 | Unknown DMC

• 1 other identifier: 235/14.05.2021
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Vitamin K; Menaquinone-7; Peritoneal dialysis; Arterial stifness; Cardiovascular; Chronic Kidney Disease; End Stage Renal Disease

Outcome Measures

Primary Outcomes (2)

• Progression of arterial stifness

  Change in pulse wave velocity

  1.5 years

• Non fatal cardiovascular events

  Number of patients presenting acute myocardial infarction, acute coronary syndrome, embolism, peripheral arterial disease and stroke

  1.5 years

Secondary Outcomes (9)

• Mortality

  1.5 years

• PD adequacy

  1.5 years

• PD clearance

  1.5 years

• Infections/peritonitis

  1.5 years

• Parathormone homeostasis

  1.5 year

Study Arms (2)

Vitamin K2

ACTIVE COMPARATOR

1mg/day per os

Dietary Supplement: MenaQ7 ®, Nattopharma, ASA, Hovik, Norway

Placebo

PLACEBO COMPARATOR

matching placebo

Dietary Supplement: MenaQ7 ®, Nattopharma, ASA, Hovik, Norway

Interventions

MenaQ7 ®, Nattopharma, ASA, Hovik, Norway DIETARY_SUPPLEMENT

daily per os supplementation of 1mg MK-7

Placebo; Vitamin K2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• At least 3 months on PD
• Life expectancy of ≥ 18 months

You may not qualify if:

• 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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• Nattopharma ASA: collaborator

Related Publications (8)

• 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: 10.2174/1570161118666200320111745.

  PMID: 32196451 RESULT

• 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):628. doi: 10.3390/ijms20030628.

  PMID: 30717170 RESULT

• 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 2020.

  PMID: 32391368 RESULT

• 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. Epub 2019 Jan 28.

  PMID: 30689181 RESULT

• 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 18F-Sodium Fluoride Positron Emission Tomography/Magnetic Resonance: The BASIK2 Rationale and Trial Design. Nutrients. 2018 Mar 21;10(4):386. doi: 10.3390/nu10040386.

  PMID: 29561783 RESULT

• 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): A study protocol for a randomized controlled trial. Medicine (Baltimore). 2020 Sep 4;99(36):e21906. doi: 10.1097/MD.0000000000021906.

  PMID: 32899022 RESULT

• 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. Hypertension. 2019 Oct;74(4):998-1004. doi: 10.1161/HYPERTENSIONAHA.119.13443. Epub 2019 Aug 12.

  PMID: 31401878 RESULT

• Roumeliotis S, Roumeliotis A, Georgianos PI, Thodis E, Schurgers LJ, Maresz K, Eleftheriadis T, Dounousi E, Tripepi G, Mallamaci F, Liakopoulos V. VItamin K In PEritonial DIAlysis (VIKIPEDIA): Rationale and study protocol for a randomized controlled trial. PLoS One. 2022 Aug 17;17(8):e0273102. doi: 10.1371/journal.pone.0273102. eCollection 2022.

  PMID: 35976944 DERIVED

MeSH Terms

Conditions

Vitamin K Deficiency; Kidney Failure, Chronic; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefanos Roumeliotis, MD, PhD

CONTACT

+302313303110; st_roumeliotis@hotmail.com

Vassilios Liakopoulos, Professor

CONTACT

+302313303110; liakopul@otenet.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Multi-centre, placebo-controlled, randomized, open-label intervention clinical trial

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 25, 2021
• Study Start: September 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: September 1, 2022
• Last Updated: May 25, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share