Incorporation of Vitamin K Into Uremic Lipoproteins

Chronic kidney disease (CKD) patients have an increased cardiovascular risk with corresponding cardiovascular calcifications. CKD patients exhibit a functional vitamin K deficiency. Calcification can be prevented by vitamin K intake. The aim of this study is to investigate the cause for the vitamin K deficiency beyond a diminished dietary vitamin K uptake.

Study Overview

• Status: Completed
• Conditions: Vitamin K Deficiency
• Intervention / Treatment: Drug: Vitamin K supplement

Detailed Description

This study is a monocentric, 1-armed interventional trial. Participants will be recruited at the University Hospital of the RWTH Aachen.

We will analyse serially collected serum from 10 dialysis patients, after ingestion of a single vitamin K supplement, compared to healthy controls. Lipoprotein fractions will be isolated and the corresponding vitamin K contents will be measured by chromatography.

The vitamin K supplement contains 3 subforms of vitamin K: vitamin K1 (1000µg), menaquinone-4 (1000µg) and menaquinone-7 (200µg).

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Aachen, Germany, 52057
    • RWTH Aachen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria

• Age ≥ 18 years
• Controls: adequate kidney function (GFR > 60 ml/min/1,73m2)
• Patients: chronic haemodialysis
• Written consent to take part in the study

Exclusion criteria

• Intake of vitamin K antagonists
• gastro-intestinal diseases interfering with vitamin K intake
• profound anemia with an Hb < 10 g/dl
• judicial or official commitment to an institution
• pregnancy and lactation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vitamin K supplement; Administration of a single dose vitamin K	Drug: Vitamin K supplement; Single dose of vitamin K supplement; Other Names: High dose vitamin K1 and K2 supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vitamin K content in lipoproteins	Assessment of vitamin K incorporation into lipoproteins	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PIVKA-II levels	PIVKA-II in serum as assessed by ELISA	1 year

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Investigators: Principal Investigator: Jürgen Floege, MD, RWTH Aachen University

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2020
• Primary Completion (Actual): July 15, 2021
• Study Completion (Actual): September 15, 2021

Study Registration Dates

• First Submitted: April 25, 2022
• First Submitted That Met QC Criteria: April 29, 2022
• First Posted (Actual): May 4, 2022

Study Record Updates

• Last Update Posted (Actual): May 4, 2022
• Last Update Submitted That Met QC Criteria: April 29, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Nutrition Disorders; Hemorrhagic Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Blood Coagulation Disorders; Vitamin K Deficiency; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Micronutrients; Antifibrinolytic Agents; Hemostatics; Coagulants; Vitamin K; Vitamins; Vitamin K 1
• Other Study ID Numbers: RWTH Aachen University

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No