Underlying Causes of Low Vitamin K Status in Hemodialysis Patients

NCT ID: NCT03493087 Phase: NA Status: COMPLETED Enrollment: 33 Completion: 2018-11-20

Conditions

Renal Insufficiency, Chronic

Interventions

Menakinon 7, Diet rich in vitamin K

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.

Primary Outcome

Δ-dp-uc-MGP (Sub-trial 5)

Source

ClinicalTrials.gov