<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/NCT04477811</url>
  </required_header>
  <id_info>
    <org_study_id>vitamin k in dialysis patients</org_study_id>
    <nct_id>NCT04477811</nct_id>
  </id_info>
  <brief_title>Comparative Study Evaluating the Effect of Vitamin K1 Versus Vitamin K2 on Vascular Calcification in Dialysis Patients</brief_title>
  <official_title>Comparative Study Evaluating the Effect of the Administration of Vitamin K1 Versus Vitamin K2 on Vascular Calcification in Dialysis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the effect of supplementation of vitamin K2 (menaquinone, MK-7)vs vitamin k1 on&#xD;
      circulating levels of calcification regulators and to assess their safety in patients on&#xD;
      regular dialysis patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Vascular calcification has emerged as an independent risk factor for cardiovascular morbidity&#xD;
      and mortality, especially in chronic kidney disease .&#xD;
&#xD;
      It has a predictive value of poor prognoses and clinical outcomes in CKD patients such as&#xD;
      overall mortality and even poor arteriovenous graft maturation .&#xD;
&#xD;
      Vitamin K is essential for the activation of matrix Gla protein (MGP), a powerful inhibitor&#xD;
      of tissue calcification, functional vitamin K deficiency may contribute to high vascular&#xD;
      calcification (VC) burden in haemodialysis patients; this is process in which mineral is&#xD;
      pathologically deposited in blood vessels, mainly in large elastic and muscular arteries such&#xD;
      as the aorta and the coronary, carotid, and peripheral arteries.&#xD;
&#xD;
      it is Prospective, Randomized,Placebo Controlled Study&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 25, 2020</start_date>
  <completion_date type="Actual">January 1, 2021</completion_date>
  <primary_completion_date type="Actual">November 1, 2020</primary_completion_date>
  <phase>Phase 2/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>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in serum level of Uncarboxylated MGP</measure>
    <time_frame>change between baseline and after 3 months</time_frame>
    <description>Measuring the change in serum level of Uncarboxylated MGP as a marker for calcification</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>parathyroid hormone</measure>
    <time_frame>change between baseline and after 3 months</time_frame>
    <description>measuring change in serum PTH</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum calcium level</measure>
    <time_frame>change between baseline and after 3 months</time_frame>
    <description>measuring the change in serum calcium level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum phosphate level</measure>
    <time_frame>change between baseline and after 3 months</time_frame>
    <description>measuring the change in phosphate level</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>End Stage Renal Disease on Dialysis</condition>
  <arm_group>
    <arm_group_label>vitamin k1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>vitamin k1 will be given 10 mg thrice a week for 3 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>vitamin k2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>vitamin k2 (menaquinone) will be given 90 ug per day orally</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo will be given daily per oral for 3 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vitamin K1</intervention_name>
    <description>vitamin k1 tablets</description>
    <arm_group_label>vitamin k1</arm_group_label>
    <other_name>Phylloquinone</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vitamin k2</intervention_name>
    <description>vitamin k2 45 ug tablets twice daily</description>
    <arm_group_label>vitamin k2</arm_group_label>
    <other_name>menaquinone</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>placebo tablets</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Both sexes aged between 18-75 years&#xD;
&#xD;
          2. Patients on HD greater than 3 months at least.&#xD;
&#xD;
          3. Stable clinical condition (no hospitalization in the previous 3 months)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hypersensitivity to vitamin k&#xD;
&#xD;
          2. Participant in an another clinical trial within the past 4 weeks.&#xD;
&#xD;
          3. Judged to be unsuitable as a subject by the attending physician.&#xD;
&#xD;
          4. Patients taking warfarin&#xD;
&#xD;
          5. Patients with known intestinal malabsorption&#xD;
&#xD;
          6. Patients with hypercoagulable state&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>sarah fahmy</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ain Shams University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ainshams University</name>
      <address>
        <city>Cairo</city>
        <zip>02</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Palit S, Kendrick J. Vascular calcification in chronic kidney disease: role of disordered mineral metabolism. Curr Pharm Des. 2014;20(37):5829-33. doi: 10.2174/1381612820666140212194926.</citation>
    <PMID>24533939</PMID>
  </reference>
  <reference>
    <citation>McCabe KM, Adams MA, Holden RM. Vitamin K status in chronic kidney disease. Nutrients. 2013 Nov 7;5(11):4390-8. doi: 10.3390/nu5114390.</citation>
    <PMID>24212088</PMID>
  </reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>July 19, 2021</last_update_submitted>
  <last_update_submitted_qc>July 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Sarah Farid</investigator_full_name>
    <investigator_title>clinical professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Failure, Chronic</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>Vitamins</mesh_term>
    <mesh_term>Vitamin K</mesh_term>
    <mesh_term>Vitamin K 2</mesh_term>
    <mesh_term>Vitamin K 1</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/NCT04477811
org study id: vitamin k in dialysis patients
nct id: NCT04477811
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
To evaluate the effect of supplementation of vitamin K2 (menaquinone, MK-7)vs vitamin k1 on
      circulating levels of calcification regulators and to assess their safety in patients on
      regular dialysis patients.
Vascular calcification has emerged as an independent risk factor for cardiovascular morbidity
      and mortality, especially in chronic kidney disease .

      It has a predictive value of poor prognoses and clinical outcomes in CKD patients such as
      overall mortality and even poor arteriovenous graft maturation .

      Vitamin K is essential for the activation of matrix Gla protein (MGP), a powerful inhibitor
      of tissue calcification, functional vitamin K deficiency may contribute to high vascular
      calcification (VC) burden in haemodialysis patients; this is process in which mineral is
      pathologically deposited in blood vessels, mainly in large elastic and muscular arteries such
      as the aorta and the coronary, carotid, and peripheral arteries.

      it is Prospective, Randomized,Placebo Controlled Study
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: change in serum level of Uncarboxylated MGP
time frame: change between baseline and after 3 months
description: Measuring the change in serum level of Uncarboxylated MGP as a marker for calcification
measure: parathyroid hormone
time frame: change between baseline and after 3 months
description: measuring change in serum PTH
measure: serum calcium level
time frame: change between baseline and after 3 months
description: measuring the change in serum calcium level
measure: serum phosphate level
time frame: change between baseline and after 3 months
description: measuring the change in phosphate level
arm group label: vitamin k1
arm group type: Active Comparator
description: vitamin k1 will be given 10 mg thrice a week for 3 months
arm group label: vitamin k2
arm group type: Active Comparator
description: vitamin k2 (menaquinone) will be given 90 ug per day orally
arm group label: placebo
arm group type: Placebo Comparator
description: placebo will be given daily per oral for 3 months
intervention type: Drug
intervention name: Vitamin K1
description: vitamin k1 tablets
arm group label: vitamin k1
other name: Phylloquinone
intervention type: Drug
intervention name: Vitamin k2
description: vitamin k2 45 ug tablets twice daily
arm group label: vitamin k2
other name: menaquinone
intervention type: Other
intervention name: placebo
description: placebo tablets
arm group label: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: sarah fahmy
role: Principal Investigator
affiliation: Ain Shams University
facility: 
country: Egypt
citation: Palit S, Kendrick J. Vascular calcification in chronic kidney disease: role of disordered mineral metabolism. Curr Pharm Des. 2014;20(37):5829-33. doi: 10.2174/1381612820666140212194926.
PMID: 24533939
citation: McCabe KM, Adams MA, Holden RM. Vitamin K status in chronic kidney disease. Nutrients. 2013 Nov 7;5(11):4390-8. doi: 10.3390/nu5114390.
PMID: 24212088
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Sarah Farid
investigator title: clinical professor
mesh term: Kidney Failure, Chronic
mesh term: Vascular Calcification
mesh term: Vitamins
mesh term: Vitamin K
mesh term: Vitamin K 2
mesh term: Vitamin K 1
sharing ipd: No