NCT05360342

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 4, 2022

Completed
Last Updated

May 4, 2022

Status Verified

April 1, 2022

Enrollment Period

1.3 years

First QC Date

April 25, 2022

Last Update Submit

April 29, 2022

Conditions

Vitamin K Deficiency

Outcome Measures

Primary Outcomes (1)

  • Vitamin K content in lipoproteins

    Assessment of vitamin K incorporation into lipoproteins

    1 year

Secondary Outcomes (1)

  • PIVKA-II levels

    1 year

Study Arms (1)

Vitamin K supplement

EXPERIMENTAL

Administration of a single dose vitamin K

Drug: Vitamin K supplement

Interventions

Vitamin K supplementDRUG

Single dose of vitamin K supplement

Also known as: High dose vitamin K1 and K2 supplement
Vitamin K supplement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Controls: adequate kidney function (GFR \> 60 ml/min/1,73m2)
  • Patients: chronic haemodialysis
  • Written consent to take part in the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RWTH Aachen University

Aachen, 52057, Germany

Location

MeSH Terms

Conditions

Vitamin K Deficiency

Interventions

Vitamin K 1

Condition Hierarchy (Ancestors)

Blood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Vitamin KNaphthoquinonesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPhytolDiterpenesTerpenesQuinonesPolycyclic Compounds

Study Officials

  • Jürgen Floege, MD

    RWTH Aachen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ.-Prof. Dr. med.

Study Record Dates

First Submitted

April 25, 2022

First Posted

May 4, 2022

Study Start

March 31, 2020

Primary Completion

July 15, 2021

Study Completion

September 15, 2021

Last Updated

May 4, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)