Incorporation of Vitamin K Into Uremic Lipoproteins | NCT05360342

Studies
Incorporation of Vitamin K Into Uremic Lipoproteins

NCT05360342

Sponsor

RWTH Aachen University

Status

Completed

Last Update Posted

May 4, 2022Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Vitamin K Deficiency

Interventions

Vitamin K supplement

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 31, 2020Actual

Primary Completion Date

Jul 15, 2021Actual

Completion Date

Sep 15, 2021Actual

First Submitted Date

Apr 25, 2022

First Submission Date that Met QC Criteria

Apr 29, 2022

First Posted Date

May 4, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2022

Last Update Posted Date

May 4, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vitamin K supplement	Experimental	Administration of a single dose vitamin K	Drug: Vitamin K supplement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitamin K supplement	Drug	Single dose of vitamin K supplement	Vitamin K supplement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Vitamin K content in lipoproteins	Assessment of vitamin K incorporation into lipoproteins	1 year

Secondary Outcomes

Measure	Description	Time Frame
PIVKA-II levels	PIVKA-II in serum as assessed by ELISA	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jürgen Floege, MD	RWTH Aachen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
RWTH Aachen University		Aachen		52057	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014813	Vitamin K Deficiency

Ancestor Terms

ID	Term
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D006474	Hemorrhagic Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010837	Vitamin K 1

Ancestor Terms

ID	Term
D014812	Vitamin K
D009285	Naphthoquinones
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons

Browse Leaves

Not provided

Browse Branches

Not provided