NCT03493087

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

February 9, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

February 22, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 10, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2018

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

6 months

First QC Date

February 9, 2018

Last Update Submit

April 17, 2019

Conditions

Renal Insufficiency, Chronic

Keywords

Dialysis, Vitamin-K, Malnutrition

Outcome Measures

Primary Outcomes (1)

  • Δ-dp-uc-MGP (Sub-trial 5)

    Comparison of concentration of dp-ucMGP in blood samples through out the intervention

    15 weeks

Secondary Outcomes (13)

  • dp-ucMGP status (Sub-trial 1)

    1 day

  • Vitamin K intake (Sub-trial 1)

    1 month

  • dp-ucMGP concentration in dialysis water (Sub-trial 2)

    1 day

  • Δ-concentration of dp-ucMGP (Sub-trial 2)

    1 day

  • Δ-weight (Sub-trial 2)

    1 day

  • +8 more secondary outcomes

Other Outcomes (4)

  • Phosphate (Sub-trial 5)

    15 weeks

  • Potassium (Sub-trial 5)

    15 weeks

  • Vitamin A (Sub-trial 5)

    15 weeks

  • +1 more other outcomes

Study Arms (2)

Menakinon-7

ACTIVE COMPARATOR

Menakinon-7 360 µg tablet by mouth, every day for 6 weeks

Dietary Supplement: Menakinon 7

Diet with vitamin K

ACTIVE COMPARATOR

Diet rich in vitamin K for 6 weeks

Dietary Supplement: Diet rich in vitamin K

Interventions

Menakinon 7DIETARY_SUPPLEMENT

Menakinon 7 - One tablet a day against vitamin K deficiency

Menakinon-7
Diet rich in vitamin KDIETARY_SUPPLEMENT

Diet with large content of vegetables and dairy products

Diet with vitamin K

Eligibility Criteria

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

You may qualify if:

  • Chronic kidney disease
  • Hemodialysis (\> 3 months) at Herlev Hospital, Nephrological department
  • Understands and are able to read danish
  • Able to collaborate on diet etc.

You may not qualify if:

  • Warfarin treatment
  • Pregnant or breastfeeding
  • Prior intake of vitamin K supplements
  • Short bowl disease, pancreatitis or other malabsorption diseases/syndromes
  • Dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev Hospital

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicMalnutrition

Interventions

Vitamin K

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

NaphthoquinonesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPhytolDiterpenesTerpenesPolycyclic Compounds

Study Officials

  • Jens Rikardt Andersen

    University of Copenhagen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 9, 2018

First Posted

April 10, 2018

Study Start

February 22, 2018

Primary Completion

August 20, 2018

Study Completion

November 20, 2018

Last Updated

April 18, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)