Incorporation of Vitamin K Into Uremic Lipoproteins

Vitamin K Deficiency Clinical Trial

Official title:

Incorporation of Vitamin K Into Uremic Lipoproteins

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05360342
• Other study ID #: RWTH Aachen University
• Status: Completed
• Phase: N/A
• Start date: March 31, 2020
• Est. completion date: September 15, 2021

Study information

• Verified date: April 2022
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 15, 2021
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vitamin K Deficiency

Intervention

Drug:
• Vitamin K supplement
Single dose of vitamin K supplement

Locations

Country	Name	City	State
Germany	RWTH Aachen University	Aachen

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitamin K content in lipoproteins	Assessment of vitamin K incorporation into lipoproteins	1 year
Secondary	PIVKA-II levels	PIVKA-II in serum as assessed by ELISA	1 year