Vitamin K Deficiency
Conditions
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).
Interventions
DRUGVitamin K supplement
Single dose of vitamin K supplement
Sponsors
RWTH Aachen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vitamin K content in lipoproteins | 1 year | Assessment of vitamin K incorporation into lipoproteins |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PIVKA-II levels | 1 year | PIVKA-II in serum as assessed by ELISA |
Countries
Germany
Outcome results
None listed