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Underlying Causes of Low Vitamin K Status in Hemodialysis Patients

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ClinicalTrials.gov Identifier: NCT03493087
Recruitment Status : Completed
First Posted : April 10, 2018
Last Update Posted : April 18, 2019
Sponsor:
Collaborator:
Herlev Hospital
Information provided by (Responsible Party):
Jens Rikardt Andersen, University of Copenhagen

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. 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.


Condition or disease Intervention/treatment Phase
Renal Insufficiency, Chronic Dietary Supplement: Menakinon 7 Dietary Supplement: Diet rich in vitamin K Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Underlying Causes of Low Vitamin K Status in Hemodialysis Patients
Actual Study Start Date : February 22, 2018
Actual Primary Completion Date : August 20, 2018
Actual Study Completion Date : November 20, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Menadione

Arm Intervention/treatment
Active Comparator: Menakinon-7
Menakinon-7 360 µg tablet by mouth, every day for 6 weeks
Dietary Supplement: Menakinon 7
Menakinon 7 - One tablet a day against vitamin K deficiency

Active Comparator: Diet with vitamin K
Diet rich in vitamin K for 6 weeks
Dietary Supplement: Diet rich in vitamin K
Diet with large content of vegetables and dairy products




Primary Outcome Measures :
  1. Δ-dp-uc-MGP (Sub-trial 5) [ Time Frame: 15 weeks ]
    Comparison of concentration of dp-ucMGP in blood samples through out the intervention


Secondary Outcome Measures :
  1. dp-ucMGP status (Sub-trial 1) [ Time Frame: 1 day ]
    Concentration of dp-ucMGP in a blood sample collected before dialysis

  2. Vitamin K intake (Sub-trial 1) [ Time Frame: 1 month ]
    Intake of vitamin K is estimated from FFQ results

  3. dp-ucMGP concentration in dialysis water (Sub-trial 2) [ Time Frame: 1 day ]
    A sample of dialysis water is tested for dp-ucMGP

  4. Δ-concentration of dp-ucMGP (Sub-trial 2) [ Time Frame: 1 day ]
    Concentration of dp-ucMGP in a blood sample collected before dialysis is compared with the concentration in a blood sample collected after dialysis

  5. Δ-weight (Sub-trial 2) [ Time Frame: 1 day ]
    The patient's weight before and after dialysis is compared

  6. Concentration of D-xylose (Sub-trial 3) [ Time Frame: 1 day ]
    Concentration of D-xylose in the blood an hour after intake of 15g of D-xylose

  7. Fat in the diet (Sub-trial 3) [ Time Frame: 1 day ]
    The amount of fat in the diet is assessed from FFQ results

  8. Δ-dp-uc-MGP (Sub-trial 4) [ Time Frame: 14 day ]
    intervention with protein is compared with the concentration in a blood sample collected after the intervention

  9. Protein in the diet (Sub-trial 4) [ Time Frame: 14 days ]
    The amount of protein in the diet is assessed from FFQ results

  10. Calcification (Sub-trial 5) [ Time Frame: 15 weeks ]
    Blood samples are analyzed via calcification propensity score, T50

  11. Quality of life (Sub-trial 5) [ Time Frame: 15 weeks ]
    The results from mental and physical well being questionnaires are compared Based on SF-36 Danish version. Eight questions with scales ranges from 1-5 with 5 being the worse outcome. The questions are looked at individually and together.

  12. The patient's perception of the presence of bruises (Sub-trial 5) [ Time Frame: 15 weeks ]
    The patient assess the changes in bruising in a questionnaire.

  13. Δ-factor 2, 7,10 concentration (Sub-trial 5) [ Time Frame: 15 weeks ]
    Comparison of concentration of factor 2,7,10 in blood samples before and after both interventions


Other Outcome Measures:
  1. Phosphate (Sub-trial 5) [ Time Frame: 15 weeks ]
    Changes in p-phosphate through out the intervention period

  2. Potassium (Sub-trial 5) [ Time Frame: 15 weeks ]
    Changes in p-potassium through out the intervention period

  3. Vitamin A (Sub-trial 5) [ Time Frame: 15 weeks ]
    Changes in p-vitamin A through out the supplement period

  4. Vitamin D (Sub-trial 5) [ Time Frame: 15 weeks ]
    Changes in p-vitamin D through out the supplement period



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Warfarin treatment
  • Pregnant or breastfeeding
  • Prior intake of vitamin K supplements
  • Short bowl disease, pancreatitis or other malabsorption diseases/syndromes
  • Dementia
  • Diabetes Mellitus (only an exclusion criterion in sub-trial 3: Absorption of vitamin K)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03493087


Locations
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Denmark
Herlev Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
University of Copenhagen
Herlev Hospital
Investigators
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Study Director: Jens Rikardt Andersen University of Copenhagen

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Responsible Party: Jens Rikardt Andersen, Associate Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT03493087     History of Changes
Other Study ID Numbers: H-17036789
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jens Rikardt Andersen, University of Copenhagen:
Dialysis, Vitamin-K, Malnutrition

Additional relevant MeSH terms:
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Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Vitamins
Vitamin K
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants