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Completed

NCT Number: NCT05360342

Incorporation of Vitamin K Into Uremic Lipoproteins

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.

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Key information

Conditions

Vitamin K Deficiency Avitaminosis Blood Coagulation Disorders Deficiency Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RWTH Aachen University

Aachen, 52057, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin K supplement

Drug

Single dose of vitamin K supplement

Other names: High dose vitamin K1 and K2 supplement

Primary outcomes

  1. Vitamin K content in lipoproteins

    Time frame: 1 year

    Assessment of vitamin K incorporation into lipoproteins

Secondary outcomes

  1. PIVKA-II levels

    Time frame: 1 year

    PIVKA-II in serum as assessed by ELISA

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 4, 2022
Registry last updated
May 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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