Back to resultsIncorporation 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
About this trial
This is an interventional basic science trial for Vitamin K Deficiency
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
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
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
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Incorporation of Vitamin K Into Uremic Lipoproteins
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