MedTrace Logo

Underlying Causes of Low Vitamin K Status in Hemodialysis Patients

NCT03493087 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2019-04-18

No results posted yet for this study

Summary

Studies have shown that patients with chronic kidney disease in hemodialysis have a low vitamin K status which is believed to be related to an increased risk of atherosclerosis and increased bleeding tendency. The underlying causes of low vitamin K status in hemodialysis patients is unknown. Thus, the aim of this study is to investigate why hemodialysis patients have a low vitamin K status and how to improve it.

This study is composed of five trials. Four of them are based on possible hypotheses to the low vitamin K status. The hypotheses are:

1. The daily intake of vitamin K is insufficient.
2. Vitamin K is removed from the blood during dialysis.
3. Absorption in the intestines is impaired.
4. The analysis method (dephosphorylated-uncarboxylated MGP) is influenced by the patients' protein intake.

The purpose of the fifth trial is to investigate solutions to improve the vitamin K status of hemodialysis. One is to improve vitamin K status through diet with an increased focus on foods with high concentrations of vitamin K while considering phosphate, potassium and fluid restrictions. The second is to increase vitamin K status through a daily supplement of 360µg Menakinon-7.

Conditions

  • Renal Insufficiency, Chronic

Interventions

DIETARY_SUPPLEMENT

Menakinon 7

Menakinon 7 - One tablet a day against vitamin K deficiency

DIETARY_SUPPLEMENT

Diet rich in vitamin K

Diet with large content of vegetables and dairy products

Sponsors & Collaborators

  • Herlev Hospital

    collaborator OTHER

  • University of Copenhagen

    lead OTHER

Principal Investigators

  • Jens Rikardt Andersen · University of Copenhagen

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-22
Primary Completion
2018-08-20
Completion
2018-11-20

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03493087 on ClinicalTrials.gov