<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/NCT02214563</url>
  </required_header>
  <id_info>
    <org_study_id>CKDR-003</org_study_id>
    <nct_id>NCT02214563</nct_id>
  </id_info>
  <brief_title>Cholecalciferol Supplementation for Anemia and Mineral and Bone Disorder in Hemodialysis Patients</brief_title>
  <acronym>CHAMBER</acronym>
  <official_title>Cholecalciferol Supplementation for Anemia and Mineral and Bone Disorder in Hemodialysis Patients (CHAMBER): A Multicenter, Double-blind, Randomized, Placebo-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Takayuki Hamano</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Japan Kidney Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Molecular Physiological Chemistry Laboratory, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Obi clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Higashikouri Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nishi clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Futaba clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Akebono clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Osaka University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether cholecalciferol supplementation decrease&#xD;
      the blood concentrations of hepcidin-25 in hemodialysis patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There are 4 arms in this study: (1) Thrice-weekly cholecalciferol supplementation (3,000 IU),&#xD;
      (2) Monthly cholecalciferol supplementation (equivalent to 9,000/week), (3) Thrice-weekly&#xD;
      placebo, and (4) Monthly placebo. The primary analyses will be done regarding 2&#xD;
      cholecalciferol groups and 2 placebo groups as one group each, and we will evaluate the&#xD;
      effect of cholecalciferol regardless of the supplementation regimen. As the secondary&#xD;
      analyses, we will examine if there is any difference between thrice-weekly and once-monthly&#xD;
      supplementation regimen.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <phase>Phase 4</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, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Serum concentrations of hepcidin-25</measure>
    <time_frame>The 3rd month</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum concentrations of hepcidin-25</measure>
    <time_frame>The 3rd day</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum concentrations of hepcidin-25</measure>
    <time_frame>The 6th month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent change of erythropoietin resistance index (ERI) overtime</measure>
    <time_frame>Up to the 6th month</time_frame>
    <description>ERI = Average weekly dose of erythropoiesis-stimulating agents (ESA) over prior 4 weeks / post-dialysis body weight (kg) / Hb (g/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood concentrations of 1,25-dihydroxyvitamin D, bone specific alkaline phosphatase (BAP), and tartrate-resistant acid phosphatase (TRAcP) 5b</measure>
    <time_frame>The 3rd month</time_frame>
    <description>In the secondary analysis, we will adjust baseline concentrations when comparing the groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood concentrations of 1,25-dihydroxyvitamin D, bone specific alkaline phosphatase (BAP), and tartrate-resistant acid phosphatase (TRAcP) 5b</measure>
    <time_frame>The 6th month</time_frame>
    <description>In the secondary analysis, we will adjust baseline concentrations when comparing the groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood concentrations of high-sensitive C reactive protein (CRP), interleukin (IL)-6, and tumor necrosis factor (TNF)-alpha</measure>
    <time_frame>The 3rd day</time_frame>
    <description>In the secondary analysis, we will adjust baseline concentrations when comparing the groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood concentrations of high-sensitive C reactive protein (CRP), interleukin (IL)-6, and tumor necrosis factor (TNF)-alpha</measure>
    <time_frame>The 3rd month</time_frame>
    <description>In the secondary analysis, we will adjust baseline concentrations when comparing the groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood concentrations of high-sensitive C reactive protein (CRP), interleukin (IL)-6, and tumor necrosis factor (TNF)-alpha</measure>
    <time_frame>The 6th month</time_frame>
    <description>In the secondary analysis, we will adjust baseline concentrations when comparing the groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood concentrations of calcium, phosphate, and intact parathyroid hormone overtime</measure>
    <time_frame>Up to the 6th month</time_frame>
    <description>In the secondary analysis, we will adjust baseline concentrations when comparing the groups.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Hypercalcemia</measure>
    <time_frame>Up to the 6th month</time_frame>
    <description>&gt;=10.5 mg/dL of albumin corrected calcium</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Kidney Failure, Chronic</condition>
  <condition>Anemia</condition>
  <condition>Vitamin D Deficiency</condition>
  <condition>Bone Diseases, Metabolic</condition>
  <arm_group>
    <arm_group_label>Thrice-weekly cholecalciferol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Capsule containing 3,000 IU of cholecalciferol will be given at the end of each hemodialysis session. Dissolved with olive oil and coated by soft capsule made of gelatin and glycerin.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Monthly cholecalciferol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Capsules containing a dose equivalent to 9,000 IU/week will be given at the end of the first hemodialysis session in the 3rd week of each month. Dissolved with olive oil and coated by soft capsule made of gelatin and glycerin.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Thrice-weekly placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Olive oil coated by soft capsule made of gelatin and glycerin.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Monthly placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Olive oil coated by soft capsule made of gelatin and glycerin.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Cholecalciferol</intervention_name>
    <description>Made for this trial by Molecular Physiological Chemistry Laboratory, Inc.</description>
    <arm_group_label>Monthly cholecalciferol</arm_group_label>
    <arm_group_label>Thrice-weekly cholecalciferol</arm_group_label>
    <other_name>vitamin D</other_name>
    <other_name>vitamin D3</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Olive oil</intervention_name>
    <arm_group_label>Monthly placebo</arm_group_label>
    <arm_group_label>Thrice-weekly placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with end-stage renal disease receiving thrice-weekly maintenance hemodialysis&#xD;
&#xD;
          -  On treatment with erythropoietin stimulating agent&#xD;
&#xD;
          -  With written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  On treatment with epoetin beta pegol as ESA&#xD;
&#xD;
          -  On supplementation with native vitamin D&#xD;
&#xD;
          -  Hypercalcemia (&gt;=10.5 mg/dL of corrected serum calcium)&#xD;
&#xD;
          -  On treatment with intravenous iron agents&#xD;
&#xD;
          -  Judged as ineligible to the randomized study by the investigators&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yoshiharu Tsubakihara, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hyogo Prefectural Nishinomiya Hospital</name>
      <address>
        <city>Nishinomiya</city>
        <state>Hyogo</state>
        <zip>662-0918</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Higashikouri hospital</name>
      <address>
        <city>Hirakata</city>
        <state>Osaka</state>
        <zip>573-0075</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine</name>
      <address>
        <city>Suita</city>
        <state>Osaka</state>
        <zip>565-0871</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akebono clinic</name>
      <address>
        <city>Kumamoto</city>
        <zip>861-4112</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Obi clinic</name>
      <address>
        <city>Osaka</city>
        <zip>543-0052</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nishi clinic</name>
      <address>
        <city>Osaka</city>
        <zip>552-0007</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Futaba clinic</name>
      <address>
        <city>Osaka</city>
        <zip>559-0013</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/24204002</url>
    <description>Link to the report which showed the negative effect of vitamin D on blood hepcidin-25 concentration in human subjects</description>
  </link>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>August 10, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>August 29, 2018</last_update_submitted>
  <last_update_submitted_qc>August 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Osaka University</investigator_affiliation>
    <investigator_full_name>Takayuki Hamano</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Vitamin D</keyword>
  <keyword>Cholecalciferol</keyword>
  <keyword>Hepcidins</keyword>
  <keyword>Renal Dialysis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bone Diseases</mesh_term>
    <mesh_term>Bone Diseases, Metabolic</mesh_term>
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Anemia</mesh_term>
    <mesh_term>Vitamin D Deficiency</mesh_term>
    <mesh_term>Metabolic Diseases</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>Ergocalciferols</mesh_term>
    <mesh_term>Cholecalciferol</mesh_term>
    <mesh_term>Vitamins</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>September 7, 2021</submitted>
    <returned>October 4, 2021</returned>
  </pending_results>
  <!-- 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/NCT02214563
org study id: CKDR-003
nct id: NCT02214563
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to determine whether cholecalciferol supplementation decrease
      the blood concentrations of hepcidin-25 in hemodialysis patients.
There are 4 arms in this study: (1) Thrice-weekly cholecalciferol supplementation (3,000 IU),
      (2) Monthly cholecalciferol supplementation (equivalent to 9,000/week), (3) Thrice-weekly
      placebo, and (4) Monthly placebo. The primary analyses will be done regarding 2
      cholecalciferol groups and 2 placebo groups as one group each, and we will evaluate the
      effect of cholecalciferol regardless of the supplementation regimen. As the secondary
      analyses, we will examine if there is any difference between thrice-weekly and once-monthly
      supplementation regimen.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Serum concentrations of hepcidin-25
time frame: The 3rd month
measure: Serum concentrations of hepcidin-25
time frame: The 3rd day
measure: Serum concentrations of hepcidin-25
time frame: The 6th month
measure: Percent change of erythropoietin resistance index (ERI) overtime
time frame: Up to the 6th month
description: ERI = Average weekly dose of erythropoiesis-stimulating agents (ESA) over prior 4 weeks / post-dialysis body weight (kg) / Hb (g/dL)
measure: Blood concentrations of 1,25-dihydroxyvitamin D, bone specific alkaline phosphatase (BAP), and tartrate-resistant acid phosphatase (TRAcP) 5b
time frame: The 3rd month
description: In the secondary analysis, we will adjust baseline concentrations when comparing the groups.
measure: Blood concentrations of 1,25-dihydroxyvitamin D, bone specific alkaline phosphatase (BAP), and tartrate-resistant acid phosphatase (TRAcP) 5b
time frame: The 6th month
description: In the secondary analysis, we will adjust baseline concentrations when comparing the groups.
measure: Blood concentrations of high-sensitive C reactive protein (CRP), interleukin (IL)-6, and tumor necrosis factor (TNF)-alpha
time frame: The 3rd day
description: In the secondary analysis, we will adjust baseline concentrations when comparing the groups.
measure: Blood concentrations of high-sensitive C reactive protein (CRP), interleukin (IL)-6, and tumor necrosis factor (TNF)-alpha
time frame: The 3rd month
description: In the secondary analysis, we will adjust baseline concentrations when comparing the groups.
measure: Blood concentrations of high-sensitive C reactive protein (CRP), interleukin (IL)-6, and tumor necrosis factor (TNF)-alpha
time frame: The 6th month
description: In the secondary analysis, we will adjust baseline concentrations when comparing the groups.
measure: Blood concentrations of calcium, phosphate, and intact parathyroid hormone overtime
time frame: Up to the 6th month
description: In the secondary analysis, we will adjust baseline concentrations when comparing the groups.
measure: Hypercalcemia
time frame: Up to the 6th month
description: >=10.5 mg/dL of albumin corrected calcium
arm group label: Thrice-weekly cholecalciferol
arm group type: Active Comparator
description: Capsule containing 3,000 IU of cholecalciferol will be given at the end of each hemodialysis session. Dissolved with olive oil and coated by soft capsule made of gelatin and glycerin.
arm group label: Monthly cholecalciferol
arm group type: Active Comparator
description: Capsules containing a dose equivalent to 9,000 IU/week will be given at the end of the first hemodialysis session in the 3rd week of each month. Dissolved with olive oil and coated by soft capsule made of gelatin and glycerin.
arm group label: Thrice-weekly placebo
arm group type: Placebo Comparator
description: Olive oil coated by soft capsule made of gelatin and glycerin.
arm group label: Monthly placebo
arm group type: Placebo Comparator
description: Olive oil coated by soft capsule made of gelatin and glycerin.
intervention type: Dietary Supplement
intervention name: Cholecalciferol
description: Made for this trial by Molecular Physiological Chemistry Laboratory, Inc.
arm group label: Monthly cholecalciferol
arm group label: Thrice-weekly cholecalciferol
other name: vitamin D
other name: vitamin D3
intervention type: Dietary Supplement
intervention name: Olive oil
arm group label: Monthly placebo
arm group label: Thrice-weekly placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Yoshiharu Tsubakihara, MD, PhD
role: Study Chair
affiliation: Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Japan
url: http://www.ncbi.nlm.nih.gov/pubmed/24204002
description: Link to the report which showed the negative effect of vitamin D on blood hepcidin-25 concentration in human subjects
responsible party type: Sponsor-Investigator
investigator affiliation: Osaka University
investigator full name: Takayuki Hamano
investigator title: Associate Professor
mesh term: Bone Diseases
mesh term: Bone Diseases, Metabolic
mesh term: Renal Insufficiency
mesh term: Kidney Failure, Chronic
mesh term: Anemia
mesh term: Vitamin D Deficiency
mesh term: Metabolic Diseases
mesh term: Vitamin D
mesh term: Ergocalciferols
mesh term: Cholecalciferol
mesh term: Vitamins
submitted: September 7, 2021
returned: October 4, 2021