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Risk Factors for Vascular Calcifications in Hemodialysis Patients: to What Extent is Vitamin K2 Deficiency Involved?

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ClinicalTrials.gov Identifier: NCT02876354
Recruitment Status : Completed
First Posted : August 23, 2016
Last Update Posted : September 20, 2016
Sponsor:
Information provided by (Responsible Party):
Mabel Aoun, Saint-Joseph University

Brief Summary:

Vitamin K2 deficiency has been shown to be profound in hemodialysis patients. It is reflected by high plasma levels of dephosphorylated-undercarboxylated Matrix Gla protein (dp-ucMGP) and seems to be correlated with vascular calcifications. Vascular calcifications can be assessed using the AC24 score on a lateral abdominal X-ray.

The aim of this study is to assess first the rate of decrease of dp-ucMGP in a hemodialysis cohort after supplementation with vitamin K2 and the correlation between this rate of decrease and the Aortic Calcification Severity (AC24) score. The factors associated with high levels of dp-ucMGP will be analyzed as well.


Condition or disease Intervention/treatment Phase
Vascular Calcifications Drug: Menaquinone Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Risk Factors for Vascular Calcifications in Hemodialysis Patients: to What Extent is Vitamin K2 Deficiency Involved?
Study Start Date : August 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Menadione

Arm Intervention/treatment
Experimental: Menaquinone 360
All patients in the study will be assigned to receive menaquinone 360 μg /d for 4 weeks.
Drug: Menaquinone
Patients on hemodialysis will be supplemented by 360 μg /d of menaquinone for 4 weeks. At baseline they will have a lateral abdominal X-Ray and dosage of dp-ucMGP. At the end of the study patients will have a second measurement of dp-ucMGP levels.
Other Name: Vitamin k2




Primary Outcome Measures :
  1. Rate of decrease of dp-ucMGP after daily supplementation with menaquinone [ Time Frame: Baseline-Four weeks ]
    We will analyze whether the percentage of decrease of dp-ucMGP in our Middle-Eastern country following vitamin k2 supplementation is similar to that reported in the previous trials in Europe.



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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:

  • Patients on chronic hemodialysis in our center older than 18 years old who sign the informed consent.

Exclusion Criteria:

  • Patients who are not eligible for a discontinuation of vitamin k antagonists

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): NCT02876354


Locations
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Lebanon
Saint-Georges Hospital
Ajaltoun, Keserwan, Lebanon
Sponsors and Collaborators
Saint-Joseph University
Investigators
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Principal Investigator: Mabel Aoun, MD Université Saint-Joseph, Beirut, Lebanon

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mabel Aoun, Head of the Department of Nephrology, Saint-Georges Hospital Ajaltoun, Saint-Joseph University
ClinicalTrials.gov Identifier: NCT02876354     History of Changes
Other Study ID Numbers: SGH001
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Mabel Aoun, Saint-Joseph University:
Hemodialysis
Vitamin k2
Vascular calcifications
Additional relevant MeSH terms:
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Calcinosis
Vascular Calcification
Calcium Metabolism Disorders
Metabolic Diseases
Vitamins
Vitamin K
Vitamin K 2
Vitamin MK 7
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants