<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/NCT01675557</url>
  </required_header>
  <id_info>
    <org_study_id>Creighton15</org_study_id>
    <nct_id>NCT01675557</nct_id>
  </id_info>
  <brief_title>Pharmacokinetic Comparison of Vitamin's D2 and D3 in Stage 5 Chronic Kidney Disease Patients on Chronic Hemodialysis</brief_title>
  <official_title>Pharmacokinetic Comparison of Vitamin's D2 and D3 in Stage 5 Chronic Kidney</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Creighton University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Creighton University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the pharmacokinetic 25(OH)D and 1,25(OH)2D responses&#xD;
      to a single oral dose of vitamin D2 or vitamin D3 in a group of Stage 5-Chronic Kidney&#xD;
      Disease subjects requiring chronic hemodialysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, single blind, controlled study. Subjects will be randomly assigned to&#xD;
      receive 1) placebo capsules (control group); 2) capsules with ergocalciferol (the vitamin D2&#xD;
      group); or 3) capsules with cholecalciferol (the vitamin D3 group).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>25(OH)D</measure>
    <time_frame>16 weeks</time_frame>
    <description>25(OH)D levels will be drawn at intervals over 16 weeks.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Chronic Kidney Disease</condition>
  <arm_group>
    <arm_group_label>Vitamin D2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>a single oral dose of vitamin D2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>a single oral dose of a placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vitamin D3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single oral dose of vitamin D3</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin D3</intervention_name>
    <description>a single oral dose of vitamin D3</description>
    <arm_group_label>Vitamin D3</arm_group_label>
    <other_name>Cholecalciferol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin D2</intervention_name>
    <description>a single oral dose of vitamin D2</description>
    <arm_group_label>Vitamin D2</arm_group_label>
    <other_name>ergocalciferol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>a single oral dose of placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  30 men and women, ages 20-65, BMI 18-30, requiring chronic hemodialysis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  They will habitually consume less than 16 oz of milk per day and get less than 10&#xD;
             hours of sun exposure per week. We will exclude those with granulomatous conditions,&#xD;
             cirrhotic liver disease, and those taking anticonvulsants, barbiturates, or steroids&#xD;
             in any form or any investigational drugs within 4 weeks. We will exclude those with&#xD;
             pregnancy or planned pregnancy, hypercalcemia (&gt;10.4 mg/dl) previously recorded,&#xD;
             chronic GI disease which would interfere with absorption, any allergy to vitamin D3,&#xD;
             or chronic vitamin D intake &gt;1,000 IU daily. Subjects will continue to take a&#xD;
             calcitriol analogue and phosphorus binder as prescribed by their nephrologist.&#xD;
             Calcitriol analogues are to be documented and remain constant throughout study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laura AG Armas, MD,MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Creighton University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Creighton University</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <last_update_submitted>February 24, 2015</last_update_submitted>
  <last_update_submitted_qc>February 24, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 26, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>chronic kidney disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</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>
  <!-- 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/NCT01675557
org study id: Creighton15
nct id: NCT01675557
lead sponsor: 
has dmc: No
The purpose of this study is to compare the pharmacokinetic 25(OH)D and 1,25(OH)2D responses
      to a single oral dose of vitamin D2 or vitamin D3 in a group of Stage 5-Chronic Kidney
      Disease subjects requiring chronic hemodialysis.
This is a randomized, single blind, controlled study. Subjects will be randomly assigned to
      receive 1) placebo capsules (control group); 2) capsules with ergocalciferol (the vitamin D2
      group); or 3) capsules with cholecalciferol (the vitamin D3 group).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: 25(OH)D
time frame: 16 weeks
description: 25(OH)D levels will be drawn at intervals over 16 weeks.
arm group label: Vitamin D2
arm group type: Active Comparator
description: a single oral dose of vitamin D2
arm group label: Placebo
arm group type: Placebo Comparator
description: a single oral dose of a placebo
arm group label: Vitamin D3
arm group type: Experimental
description: A single oral dose of vitamin D3
intervention type: Dietary Supplement
intervention name: Vitamin D3
description: a single oral dose of vitamin D3
arm group label: Vitamin D3
other name: Cholecalciferol
intervention type: Dietary Supplement
intervention name: Vitamin D2
description: a single oral dose of vitamin D2
arm group label: Vitamin D2
other name: ergocalciferol
intervention type: Dietary Supplement
intervention name: Placebo
description: a single oral dose of placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Laura AG Armas, MD,MS
role: Principal Investigator
affiliation: Creighton University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Vitamin D
mesh term: Ergocalciferols
mesh term: Cholecalciferol
mesh term: Vitamins