Incorporation of Vitamin K Into Uremic Lipoproteins

RWTH Aachen University

Status: Completed

Conditions: Vitamin K Deficiency

Treatments: Drug: Vitamin K supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT05360342

RWTH Aachen University

Details and patient eligibility

About

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.

Full 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).

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Vitamin K supplement

Experimental group

Description:

Administration of a single dose vitamin K

Treatment:

Drug: Vitamin K supplement