<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/NCT03305536</url>
  </required_header>
  <id_info>
    <org_study_id>NC27082017</org_study_id>
    <nct_id>NCT03305536</nct_id>
  </id_info>
  <brief_title>Decalcification of the Aortic Valve by Vitamin K2 (Menaquinone-7)</brief_title>
  <acronym>DECAV-K2</acronym>
  <official_title>Decalcification of the Aortic Valve by Vitamin K2 (Menaquinone-7)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hopital St. Georges, Ajaltoun</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Omicron Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nattopharma ASA</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Hopital St. Georges, Ajaltoun</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aortic Stenosis is a common but fatal disease when it becomes symptomatic, specially if not&#xD;
      treated. Until now surgery remains the only reliable and effective treatment.&#xD;
&#xD;
      In this study, the investigators will examine the effect of high dose of Menaquinone-7 (MK-7)&#xD;
      supplementation (1000 mcg)/day on the progression of the aortic valve disease. The&#xD;
      investigators hypothesize that MK-7 supplementation may slow or even reverse the progression&#xD;
      of the disease process.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a randomized clinical trial that will use Cardiac Echography and multi-detector&#xD;
      computed tomography to compare the changes in the Aortic Valve Calcification Score (AVCS)&#xD;
      over 3 years when using:&#xD;
&#xD;
        1. 1000 mcg/d Vitamin K2 (menaquinone-7) + 5000 IU/d Vitamin D3&#xD;
&#xD;
        2. 5000 IU/d Vitamin D3 as a control group&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2, 2018</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <phase>Phase 2</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evolution of the Aortic Valve Hemodynamic measured by echography: Change in Gradients in (mm Hg)</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Evolution of the Aortic Valve Hemodynamic measured by echography: Change in Surface area in (cm2/m2)</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Evolution of the Aortic Valve Hemodynamic measured by echography: Change in V max in (m/sec)</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Activation of the MGP measured by the dp-uc MGP level which is a marker of vascular calcification.</measure>
    <time_frame>3 years</time_frame>
    <description>Lowering of dephosphorelated-undercarboxylated matrix Gla protein (dp-ucMGP picomol/l)&#xD;
Reduction of the Aortic Valve Calcification Score(AVCS)&#xD;
Improvement of dyspnea according to the New York Heart Association Classification(NYHA)&#xD;
Improvement of the quality of life of the patients( physical activity, mobility)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction of the Aortic Valve calcification measured by CT Scan</measure>
    <time_frame>3 years</time_frame>
    <description>Reduction of the Aortic Valve Calcification Score (AVCS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of dyspnea (at rest and effort)</measure>
    <time_frame>3 years</time_frame>
    <description>Improvement of dyspnea according to the New York Heart Association Classification(NYHA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of the quality of life of the patients</measure>
    <time_frame>3 years</time_frame>
    <description>Every patient have to feel the WHOQOL-BREF, Questionnaire, June 1997, Updated 1/10/2014</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Aortic Valve Disease</condition>
  <arm_group>
    <arm_group_label>Interventional</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1000 mcg/day of Vitamin K2 + 5000 IU/day Vitamin D3 as a treatment to decalcifiy the valve</description>
  </arm_group>
  <arm_group>
    <arm_group_label>interventional</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>5000 IU/day of Vitamin D3 will be given to measure the progression of the disease along the time of the study</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin K2 (Menaquinone 7) + Vitamin D3</intervention_name>
    <description>Vitamin K2 + Vitamin D3 arm will be compared with Vitamin D3 arm to slow of reverse the progression of the disease</description>
    <arm_group_label>Interventional</arm_group_label>
    <arm_group_label>interventional</arm_group_label>
    <other_name>K2/D3</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  AVCS &gt; 300 without aortic valve stenosis requiring operation&#xD;
&#xD;
          -  Focus on patients with:&#xD;
&#xD;
               1. Bicuspid aortic valve&#xD;
&#xD;
               2. Dialysis or CKD&#xD;
&#xD;
               3. Statin treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of Vitamin K antagonist&#xD;
&#xD;
          -  Malabsorption Problem&#xD;
&#xD;
          -  LVEF &lt; 40%&#xD;
&#xD;
          -  A life expectancy &lt; 3 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Rodoplh Frangi, MD</last_name>
    <phone>00961 9 234 202</phone>
    <phone_ext>1100</phone_ext>
    <email>drfrangi@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hopital Saint-George Ajaltoun</name>
      <address>
        <city>Beirut</city>
        <country>Lebanon</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rodolphe Frangi, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Lebanon</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>October 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>August 8, 2019</last_update_submitted>
  <last_update_submitted_qc>August 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hopital St. Georges, Ajaltoun</investigator_affiliation>
    <investigator_full_name>Rodolph Frangi</investigator_full_name>
    <investigator_title>Head of Department of Thoracic and Cardiovascular surgery</investigator_title>
  </responsible_party>
  <keyword>AVD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
    <mesh_term>Vitamins</mesh_term>
    <mesh_term>Vitamin K</mesh_term>
    <mesh_term>Vitamin K 2</mesh_term>
    <mesh_term>Menaquinone 7</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03305536
org study id: NC27082017
nct id: NCT03305536
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Aortic Stenosis is a common but fatal disease when it becomes symptomatic, specially if not
      treated. Until now surgery remains the only reliable and effective treatment.

      In this study, the investigators will examine the effect of high dose of Menaquinone-7 (MK-7)
      supplementation (1000 mcg)/day on the progression of the aortic valve disease. The
      investigators hypothesize that MK-7 supplementation may slow or even reverse the progression
      of the disease process.
The study is a randomized clinical trial that will use Cardiac Echography and multi-detector
      computed tomography to compare the changes in the Aortic Valve Calcification Score (AVCS)
      over 3 years when using:

        1. 1000 mcg/d Vitamin K2 (menaquinone-7) + 5000 IU/d Vitamin D3

        2. 5000 IU/d Vitamin D3 as a control group
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Evolution of the Aortic Valve Hemodynamic measured by echography: Change in Gradients in (mm Hg)
time frame: 3 years
measure: Evolution of the Aortic Valve Hemodynamic measured by echography: Change in Surface area in (cm2/m2)
time frame: 3 years
measure: Evolution of the Aortic Valve Hemodynamic measured by echography: Change in V max in (m/sec)
time frame: 3 years
measure: Activation of the MGP measured by the dp-uc MGP level which is a marker of vascular calcification.
time frame: 3 years
description: Lowering of dephosphorelated-undercarboxylated matrix Gla protein (dp-ucMGP picomol/l)
Reduction of the Aortic Valve Calcification Score(AVCS)
Improvement of dyspnea according to the New York Heart Association Classification(NYHA)
Improvement of the quality of life of the patients( physical activity, mobility)
measure: Reduction of the Aortic Valve calcification measured by CT Scan
time frame: 3 years
description: Reduction of the Aortic Valve Calcification Score (AVCS)
measure: Improvement of dyspnea (at rest and effort)
time frame: 3 years
description: Improvement of dyspnea according to the New York Heart Association Classification(NYHA)
measure: Improvement of the quality of life of the patients
time frame: 3 years
description: Every patient have to feel the WHOQOL-BREF, Questionnaire, June 1997, Updated 1/10/2014
arm group label: Interventional
arm group type: Active Comparator
description: 1000 mcg/day of Vitamin K2 + 5000 IU/day Vitamin D3 as a treatment to decalcifiy the valve
arm group label: interventional
arm group type: Active Comparator
description: 5000 IU/day of Vitamin D3 will be given to measure the progression of the disease along the time of the study
intervention type: Dietary Supplement
intervention name: Vitamin K2 (Menaquinone 7) + Vitamin D3
description: Vitamin K2 + Vitamin D3 arm will be compared with Vitamin D3 arm to slow of reverse the progression of the disease
arm group label: Interventional
arm group label: interventional
other name: K2/D3
criteria: 
gender: All
minimum age: 30 Years
maximum age: 85 Years
healthy volunteers: No
last name: Rodoplh Frangi, MD
phone: 00961 9 234 202
phone ext: 1100
email: drfrangi@hotmail.com
facility: 
status: Recruiting
contact: 
country: Lebanon
responsible party type: Principal Investigator
investigator affiliation: Hopital St. Georges, Ajaltoun
investigator full name: Rodolph Frangi
investigator title: Head of Department of Thoracic and Cardiovascular surgery
mesh term: Aortic Valve Disease
mesh term: Vitamin D
mesh term: Vitamins
mesh term: Vitamin K
mesh term: Vitamin K 2
mesh term: Menaquinone 7
sharing ipd: Undecided