<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/NCT04496921</url>
  </required_header>
  <id_info>
    <org_study_id>VITK-FK</org_study_id>
    <nct_id>NCT04496921</nct_id>
  </id_info>
  <brief_title>Vitamin K Supplementation to Reduce Deficiencies in Adults With Cystic Fibrosis</brief_title>
  <acronym>VITK-FK</acronym>
  <official_title>Vitamin K Supplementation to Reduce Deficiencies in Adults With Cystic Fibrosis : A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut de Recherches Cliniques de Montreal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Université de Montréal</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Institut de Recherches Cliniques de Montreal</source>
  <oversight_info>
    <has_dmc>No</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>
      Cystic fibrosis (CF) patients are at risk for vitamin K deficiencies. Supplementation for&#xD;
      fat-soluble vitamins A, D, and E is well established, but in CF, there is little data for&#xD;
      vitamin K concerning the optimal dose and frequency of supplementation. Beyond its known role&#xD;
      in coagulation, research has highlighted the role of vitamin K for bone health and the&#xD;
      control of blood sugar levels. However, after pulmonary complications, the risk of diabetes&#xD;
      and bone diseases are two important and frequent complications of CF. Patients with CF being&#xD;
      at risk of vitamin K deficiencies, this vitamin could play a role in these complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators propose a pilot study (carried out to assess its feasibility on a larger&#xD;
      scale) to evaluate if a supplement of vitamin K improves vitamin K serum levels in CF&#xD;
      patients by comparing:&#xD;
&#xD;
        -  Group A: a vitamin K supplement of 2mg, every day for 6 months&#xD;
&#xD;
        -  Group B: a vitamin K supplement of 7mg, twice a week for 6 months&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Clinical care of patients with CF changed following COVID-19 pandemic (OGTT not performed at&#xD;
    the CF clinic since March 2020); in consequence, this study is no longer feasible.&#xD;
  </why_stopped>
  <start_date type="Actual">August 10, 2020</start_date>
  <completion_date type="Actual">August 16, 2021</completion_date>
  <primary_completion_date type="Actual">August 16, 2021</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>Group A: vitamin K supplement of 2 mg, once a day for 6 months&#xD;
Group B: vitamin K supplement of 7 mg, twice a week for 6 months</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in serum vitamin K levels from baseline at 6 months</measure>
    <time_frame>0, 3 and 6 months</time_frame>
    <description>Impact of supplementation on vitamin K serum levels</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in osteocalcin levels from baseline at 6 months</measure>
    <time_frame>0, 3 and 6 months</time_frame>
    <description>Impact of supplementation on osteocalcin levels (Total and uncarboxylated)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's perception and side effects of the supplement</measure>
    <time_frame>6 months</time_frame>
    <description>Visual analogue scale questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bone marker levels</measure>
    <time_frame>0, 3 and 6 months</time_frame>
    <description>Impact of supplementation on bone marker C-Telopeptide</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic marker levels</measure>
    <time_frame>0, 3 and 6 months</time_frame>
    <description>Impact of supplementation on HbA1c levels and fructosamine levels</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Cystic Fibrosis</condition>
  <arm_group>
    <arm_group_label>Vitamin K supplement, dose #1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Vitamin K supplementation with dose #1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vitamin K supplement, dose #2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Vitamin K supplementation with dose #2</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin K supplementation, dose #1</intervention_name>
    <description>Vitamin K supplement : 2mg, once a day, for 6 months. Complete biochemical profile, weight and size (body mass index), drugs list, pulmonary function by spirometry (FEV, etc.). Food frequency questionnaire.</description>
    <arm_group_label>Vitamin K supplement, dose #1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin K supplementation, dose #2</intervention_name>
    <description>Vitamin K supplement : 7mg, twice a week, for 6 months. Complete biochemical profile, weight and size (body mass index), drugs list, pulmonary function by spirometry (FEV, etc.). Food frequency questionnaire.</description>
    <arm_group_label>Vitamin K supplement, dose #2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with CF&#xD;
&#xD;
          -  Aged above 18 years&#xD;
&#xD;
          -  Pancreatic insufficient&#xD;
&#xD;
          -  Subjects with an OGTT test in the last 12 months or subjects who are diabetic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Receive or have received, in the last 6 months, a supplement of vitamin K (dose&#xD;
             greater than 500 mcg per day)&#xD;
&#xD;
          -  Subjects with a pulmonary function under 30%&#xD;
&#xD;
          -  Subjects with severe gastrointestinal disease (Crohn disease, coeliac disease and&#xD;
             recent (&lt;1 year) history of intestinal occlusion).&#xD;
&#xD;
          -  Subjects with a history of liver disease (severe or transplant)&#xD;
&#xD;
          -  Known allergy or intolerance to phylloquinone (oral form of vitamin K)&#xD;
&#xD;
          -  Pregnancy (current or planned in the next 6 months)&#xD;
&#xD;
          -  Subjects with signs of active secondary infections should wait at least 1 month after&#xD;
             the end of antibiotic treatment in order to be included in the study.&#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>Rémi Rabasa-Lhoret, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Montreal Clinical Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Montreal Clinical Research Institute (IRCM)</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H2W1R7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHUM</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>August 16, 2021</last_update_submitted>
  <last_update_submitted_qc>August 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vitamin K</keyword>
  <keyword>Supplementation</keyword>
  <keyword>Nutrition</keyword>
  <keyword>Diabetes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamins</mesh_term>
    <mesh_term>Vitamin K</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04496921
org study id: VITK-FK
nct id: NCT04496921
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cystic fibrosis (CF) patients are at risk for vitamin K deficiencies. Supplementation for
      fat-soluble vitamins A, D, and E is well established, but in CF, there is little data for
      vitamin K concerning the optimal dose and frequency of supplementation. Beyond its known role
      in coagulation, research has highlighted the role of vitamin K for bone health and the
      control of blood sugar levels. However, after pulmonary complications, the risk of diabetes
      and bone diseases are two important and frequent complications of CF. Patients with CF being
      at risk of vitamin K deficiencies, this vitamin could play a role in these complications.
The investigators propose a pilot study (carried out to assess its feasibility on a larger
      scale) to evaluate if a supplement of vitamin K improves vitamin K serum levels in CF
      patients by comparing:

        -  Group A: a vitamin K supplement of 2mg, every day for 6 months

        -  Group B: a vitamin K supplement of 7mg, twice a week for 6 months
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Group A: vitamin K supplement of 2 mg, once a day for 6 months
Group B: vitamin K supplement of 7 mg, twice a week for 6 months
primary purpose: Prevention
masking: None (Open Label)
measure: Change in serum vitamin K levels from baseline at 6 months
time frame: 0, 3 and 6 months
description: Impact of supplementation on vitamin K serum levels
measure: Change in osteocalcin levels from baseline at 6 months
time frame: 0, 3 and 6 months
description: Impact of supplementation on osteocalcin levels (Total and uncarboxylated)
measure: Patient's perception and side effects of the supplement
time frame: 6 months
description: Visual analogue scale questionnaire
measure: Bone marker levels
time frame: 0, 3 and 6 months
description: Impact of supplementation on bone marker C-Telopeptide
measure: Glycemic marker levels
time frame: 0, 3 and 6 months
description: Impact of supplementation on HbA1c levels and fructosamine levels
arm group label: Vitamin K supplement, dose #1
arm group type: Active Comparator
description: Vitamin K supplementation with dose #1
arm group label: Vitamin K supplement, dose #2
arm group type: Active Comparator
description: Vitamin K supplementation with dose #2
intervention type: Dietary Supplement
intervention name: Vitamin K supplementation, dose #1
description: Vitamin K supplement : 2mg, once a day, for 6 months. Complete biochemical profile, weight and size (body mass index), drugs list, pulmonary function by spirometry (FEV, etc.). Food frequency questionnaire.
arm group label: Vitamin K supplement, dose #1
intervention type: Dietary Supplement
intervention name: Vitamin K supplementation, dose #2
description: Vitamin K supplement : 7mg, twice a week, for 6 months. Complete biochemical profile, weight and size (body mass index), drugs list, pulmonary function by spirometry (FEV, etc.). Food frequency questionnaire.
arm group label: Vitamin K supplement, dose #2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rémi Rabasa-Lhoret, MD, PhD
role: Principal Investigator
affiliation: Montreal Clinical Research Institute
facility: 
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Cystic Fibrosis
mesh term: Fibrosis
mesh term: Vitamins
mesh term: Vitamin K
sharing ipd: No