<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01675206</url>
  </required_header>
  <id_info>
    <org_study_id>2010/066</org_study_id>
    <nct_id>NCT01675206</nct_id>
  </id_info>
  <brief_title>Dose Defining Study for the Administration of Vitamin K2 Supplements in Hemodialysis Patients</brief_title>
  <official_title>Randomized Prospective Open Interventional Multi-centre Study on Finding the Optimal Dose of Vitamin K2 Supplements for Hemodialysis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rogier Caluwe</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Onze Lieve Vrouw Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims at finding the optimal dose of Vitamin K2 supplementation in hemodialysis&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During the past few years evidence is emerging for a role of Matrix Gla Protein (MGP) as one&#xD;
      of the most powerful inhibitors of vascular calcification (Shurgers LJ et al. Thromb Haemost&#xD;
      2008; 100: 593-603). MGP is a Vitamin K dependent protein. This means that he presence of&#xD;
      Vitamin K2 is required to promote the gamma-carboxylation process turning MGP in its&#xD;
      carboxylated and active form. Recent data show that dp-uc MGP correlates well with Vitamin K&#xD;
      status (Cranenburg CM et al. Thrombosis and Haemostasis 2010; 104/4: 811-822).&#xD;
&#xD;
      It is widely recognized that patients with renal insufficiency treated with hemodialysis are&#xD;
      prone to accelerated vascular calcification resulting in excess cardiovascular morbidity and&#xD;
      mortality (Goodman WG et al. N Engl J Med 2000; 342: 1478-1483).&#xD;
&#xD;
      Consequently, the administration of Vitamin K2 supplements may protect hemodialysis patients&#xD;
      against accelerated vascular calcification by enhancing the gamma-carboxylation process of&#xD;
      MGP. However, the optimal dose of Vitamin K2 required to achieve these results remains to be&#xD;
      defined&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2011</start_date>
  <completion_date type="Actual">April 2012</completion_date>
  <primary_completion_date type="Actual">September 2011</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>percentage of reduction in dp-ucMGP after 8 weeks of Vitamin K2 supplementation</measure>
    <time_frame>8 weeks</time_frame>
    <description>this study aims at verifying whether higher doses of Vitamin K2 supplementation result in an increased reduction in dp-ucMGP</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of adverse reactions associated with Vitamin K2 intake</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">165</enrollment>
  <condition>Vascular Calcification</condition>
  <arm_group>
    <arm_group_label>360 µg Vit K2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Administration of 360 µg of Vitamin K2 thrice weekly</description>
  </arm_group>
  <arm_group>
    <arm_group_label>720 µg Vit K2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Administration of 720 µg of Vitamin K2 thrice weekly</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1080 µg Vit K2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Administration of 1080 µg of Vitamin K2 thrice weekly</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin K2 supplementation</intervention_name>
    <arm_group_label>1080 µg Vit K2</arm_group_label>
    <arm_group_label>360 µg Vit K2</arm_group_label>
    <arm_group_label>720 µg Vit K2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age ≥18 year&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
          -  end stage renal disease treated with chronic hemodialysis at least three times a week&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  coumarin treatment&#xD;
&#xD;
          -  known intestinal malabsorption&#xD;
&#xD;
          -  inability to take oral medication&#xD;
&#xD;
          -  medical conditions with a considerable probability for death within 2 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rogier Caluwé, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>OLV Hospital Aalst Belgium</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bruno Van Vlem, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>OLV Hospital Aalst Belgium</affiliation>
  </overall_official>
  <overall_official>
    <last_name>An Devriese, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>AZ St.-Jan Brugge Belgium</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stefaan Vandecasteele, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>AZ St.-Jan Brugge Belgium</affiliation>
  </overall_official>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>August 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>August 25, 2012</last_update_submitted>
  <last_update_submitted_qc>August 25, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 29, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Onze Lieve Vrouw Hospital</investigator_affiliation>
    <investigator_full_name>Rogier Caluwe</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Vascular calcification</keyword>
  <keyword>Hemodialysis</keyword>
  <keyword>Matrix Gla Protein</keyword>
  <keyword>Vitamin K2</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcinosis</mesh_term>
    <mesh_term>Vascular Calcification</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin K</mesh_term>
    <mesh_term>Vitamin K 2</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01675206
org study id: 2010/066
nct id: NCT01675206
lead sponsor: 
has dmc: No
This study aims at finding the optimal dose of Vitamin K2 supplementation in hemodialysis
      patients.
During the past few years evidence is emerging for a role of Matrix Gla Protein (MGP) as one
      of the most powerful inhibitors of vascular calcification (Shurgers LJ et al. Thromb Haemost
      2008; 100: 593-603). MGP is a Vitamin K dependent protein. This means that he presence of
      Vitamin K2 is required to promote the gamma-carboxylation process turning MGP in its
      carboxylated and active form. Recent data show that dp-uc MGP correlates well with Vitamin K
      status (Cranenburg CM et al. Thrombosis and Haemostasis 2010; 104/4: 811-822).

      It is widely recognized that patients with renal insufficiency treated with hemodialysis are
      prone to accelerated vascular calcification resulting in excess cardiovascular morbidity and
      mortality (Goodman WG et al. N Engl J Med 2000; 342: 1478-1483).

      Consequently, the administration of Vitamin K2 supplements may protect hemodialysis patients
      against accelerated vascular calcification by enhancing the gamma-carboxylation process of
      MGP. However, the optimal dose of Vitamin K2 required to achieve these results remains to be
      defined
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: percentage of reduction in dp-ucMGP after 8 weeks of Vitamin K2 supplementation
time frame: 8 weeks
description: this study aims at verifying whether higher doses of Vitamin K2 supplementation result in an increased reduction in dp-ucMGP
measure: Assessment of adverse reactions associated with Vitamin K2 intake
time frame: 8 weeks
arm group label: 360 µg Vit K2
arm group type: Active Comparator
description: Administration of 360 µg of Vitamin K2 thrice weekly
arm group label: 720 µg Vit K2
arm group type: Active Comparator
description: Administration of 720 µg of Vitamin K2 thrice weekly
arm group label: 1080 µg Vit K2
arm group type: Active Comparator
description: Administration of 1080 µg of Vitamin K2 thrice weekly
intervention type: Dietary Supplement
intervention name: Vitamin K2 supplementation
arm group label: 1080 µg Vit K2
arm group label: 360 µg Vit K2
arm group label: 720 µg Vit K2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rogier Caluwé, MD
role: Principal Investigator
affiliation: OLV Hospital Aalst Belgium
last name: Bruno Van Vlem, MD, PhD
role: Study Chair
affiliation: OLV Hospital Aalst Belgium
last name: An Devriese, MD, PhD
role: Study Chair
affiliation: AZ St.-Jan Brugge Belgium
last name: Stefaan Vandecasteele, MD, PhD
role: Study Chair
affiliation: AZ St.-Jan Brugge Belgium
responsible party type: Sponsor-Investigator
investigator affiliation: Onze Lieve Vrouw Hospital
investigator full name: Rogier Caluwe
investigator title: MD
mesh term: Calcinosis
mesh term: Vascular Calcification
mesh term: Vitamin K
mesh term: Vitamin K 2