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Incorporation of Vitamin K Into Uremic Lipoproteins

Primary Purpose

Vitamin K Deficiency

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Vitamin K supplement
Sponsored by
RWTH Aachen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Vitamin K Deficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • RWTH Aachen University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vitamin K supplement

Arm Description

Administration of a single dose vitamin K

Outcomes

Primary Outcome Measures

Vitamin K content in lipoproteins
Assessment of vitamin K incorporation into lipoproteins

Secondary Outcome Measures

PIVKA-II levels
PIVKA-II in serum as assessed by ELISA

Full Information

First Posted
April 25, 2022
Last Updated
April 29, 2022
Sponsor
RWTH Aachen University
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1. Study Identification

Unique Protocol Identification Number
NCT05360342
Brief Title
Incorporation of Vitamin K Into Uremic Lipoproteins
Official Title
Incorporation of Vitamin K Into Uremic Lipoproteins
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 31, 2020 (Actual)
Primary Completion Date
July 15, 2021 (Actual)
Study Completion Date
September 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RWTH Aachen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin K Deficiency

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin K supplement
Arm Type
Experimental
Arm Description
Administration of a single dose vitamin K
Intervention Type
Drug
Intervention Name(s)
Vitamin K supplement
Other Intervention Name(s)
High dose vitamin K1 and K2 supplement
Intervention Description
Single dose of vitamin K supplement
Primary Outcome Measure Information:
Title
Vitamin K content in lipoproteins
Description
Assessment of vitamin K incorporation into lipoproteins
Time Frame
1 year
Secondary Outcome Measure Information:
Title
PIVKA-II levels
Description
PIVKA-II in serum as assessed by ELISA
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jürgen Floege, MD
Organizational Affiliation
RWTH Aachen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
RWTH Aachen University
City
Aachen
ZIP/Postal Code
52057
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Incorporation of Vitamin K Into Uremic Lipoproteins

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