Incorporation of Vitamin K Into Uremic Lipoproteins

NCT ID: NCT05360342

Last Updated: 2022-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-31

Study Completion Date

2021-09-15

Brief Summary

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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

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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).

Conditions

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Vitamin K Deficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Vitamin K supplement

Administration of a single dose vitamin K

Group Type EXPERIMENTAL

Vitamin K supplement

Intervention Type DRUG

Single dose of vitamin K supplement

Interventions

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Vitamin K supplement

Single dose of vitamin K supplement

Intervention Type DRUG

Other Intervention Names

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High dose vitamin K1 and K2 supplement

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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RWTH Aachen University

OTHER

Sponsor Role lead

Responsible Party

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Jürgen Floege

Univ.-Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jürgen Floege, MD

Role: PRINCIPAL_INVESTIGATOR

RWTH Aachen University

Locations

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RWTH Aachen University

Aachen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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RWTH Aachen University

Identifier Type: -

Identifier Source: org_study_id

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