<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/NCT02234544</url>
  </required_header>
  <id_info>
    <org_study_id>14-0378</org_study_id>
    <nct_id>NCT02234544</nct_id>
  </id_info>
  <brief_title>Effect of an Inhibitor of Cholesterol Absorption on Vitamin D Levels</brief_title>
  <official_title>Estudo clínico Randomizado, Controlado e Duplo-cego do Impacto da inibição de um Transportador de Membrana do Colesterol na absorção da Vitamina D</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Rio Grande do Sul</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Rio Grande do Sul</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Double-blind randomized controlled trial to evaluate the serum levels of 25(OH)D after a&#xD;
      single oral dose of cholecalciferol 50,000 IU plus ezetimibe or placebo.&#xD;
&#xD;
      Differences between the serum levels of 25(OH)D in response to cholecalciferol plus ezetimibe&#xD;
      compared to cholecalciferol plus placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives: To evaluate the serum levels of 25(OH)D after a single oral dose of&#xD;
      cholecalciferol 50,000 IU plus ezetimibe or placebo.&#xD;
&#xD;
      Experimental design: Double-blind randomized controlled trial. Research location: Porto&#xD;
      Alegre Clinical Hospital (HCPA), RS, Brazil. Participants: Medical residents of the HCPA.&#xD;
      Intervention: The groups will be randomized to ezetimibe 10 mg for 5 days or placebo. On the&#xD;
      fifth day, they should came after an overnight fast for blood tests collection [25(OH)D, PTH,&#xD;
      calcium, albumin]. Next, all participants will receive orally a cholecalciferol 50,000 IU&#xD;
      capsule and a snack containing 15g of fat. Participants will return 14 days after that for a&#xD;
      second blood test.&#xD;
&#xD;
      Statistical Analysis: Paired samples t-test or Wilcoxon signed rank-test will be used for&#xD;
      comparing variables in two distinct moments (before cholecalciferol and 14 days after). The&#xD;
      correlation between the numerical variables will be evaluated by the Spearman's correlation&#xD;
      coefficient. A p value of less than 0.05 was considered statistically significant.&#xD;
&#xD;
      Expected results: Differences between the serum levels of 25(OH)D in response to&#xD;
      cholecalciferol plus ezetimibe compared to cholecalciferol plus placebo.&#xD;
&#xD;
      Cost/benefit of the project: This is a low budget and minimal risks study that will&#xD;
      contribute to a better understanding of the absorptive process of vitamin D and the effect of&#xD;
      ezetimibe on its absorption.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</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>Factorial Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>25-hydroxyvitamin D</measure>
    <time_frame>up to 24 months</time_frame>
    <description>The groups will be randomized to ezetimibe 10 mg for 5 days or placebo. On the fifth day, they should came after an overnight fast for blood tests collection [25(OH)D, PTH, calcium, albumin]. Next, all participants will receive orally a cholecalciferol 50,000 IU capsule and a snack containing 15g of fat. Participants will return 14 days after that for a second blood test.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Vitamin D Deficiency</condition>
  <arm_group>
    <arm_group_label>Placebo + Cholecalciferol</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The groups will be randomized to ezetimibe or placebo. All participants will receive orally a cholecalciferol capsule.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ezetimibe + Cholecalciferol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The groups will be randomized to ezetimibe or placebo. All participants will receive orally a cholecalciferol capsule.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ezetimibe</intervention_name>
    <description>The groups will be randomized to ezetimibe 10 mg for 5 days or placebo. On the fifth day, they should came after an overnight fast for blood tests collection [25(OH)D, PTH, calcium, albumin]. Next, all participants will receive orally a cholecalciferol 50,000 IU capsule and a snack containing 15g of fat. Participants will return 14 days after that for a second blood test.</description>
    <arm_group_label>Ezetimibe + Cholecalciferol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cholecalciferol</intervention_name>
    <description>All participants will receive orally a cholecalciferol 50,000 IU capsule and a snack containing 15g of fat. Participants will return 14 days after that for a second blood test.</description>
    <arm_group_label>Ezetimibe + Cholecalciferol</arm_group_label>
    <arm_group_label>Placebo + Cholecalciferol</arm_group_label>
    <other_name>Vitamin D</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>The groups will be randomized to ezetimibe 10 mg for 5 days or placebo. On the fifth day, they should came after an overnight fast for blood tests collection [25(OH)D, PTH, calcium, albumin]. Next, all participants will receive orally a cholecalciferol 50,000 IU capsule and a snack containing 15g of fat. Participants will return 14 days after that for a second blood test.</description>
    <arm_group_label>Placebo + Cholecalciferol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Medical students of the HCPA&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Body mass index &gt;+ 25 or &lt; 18.5 kg/m2&#xD;
&#xD;
          -  Known liver, kidney or endocrine disease&#xD;
&#xD;
          -  Known malabsorption&#xD;
&#xD;
          -  Use of supplements of calcium and/or vitamin Danticonvulsants, barbiturates, or&#xD;
             glucocorticoids&#xD;
&#xD;
          -  Travel outside the Brazilian south region during the previous 120 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital de Clínicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90035-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>August 31, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>April 7, 2015</last_update_submitted>
  <last_update_submitted_qc>April 7, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 9, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Rio Grande do Sul</investigator_affiliation>
    <investigator_full_name>Mariana Costa Silva</investigator_full_name>
    <investigator_title>MD, MSc</investigator_title>
  </responsible_party>
  <keyword>vitamin D</keyword>
  <keyword>absorption</keyword>
  <keyword>ezetimibe</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D Deficiency</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>Cholecalciferol</mesh_term>
    <mesh_term>Ezetimibe</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/NCT02234544
org study id: 14-0378
nct id: NCT02234544
lead sponsor: 
has dmc: Yes
Double-blind randomized controlled trial to evaluate the serum levels of 25(OH)D after a
      single oral dose of cholecalciferol 50,000 IU plus ezetimibe or placebo.

      Differences between the serum levels of 25(OH)D in response to cholecalciferol plus ezetimibe
      compared to cholecalciferol plus placebo.
Objectives: To evaluate the serum levels of 25(OH)D after a single oral dose of
      cholecalciferol 50,000 IU plus ezetimibe or placebo.

      Experimental design: Double-blind randomized controlled trial. Research location: Porto
      Alegre Clinical Hospital (HCPA), RS, Brazil. Participants: Medical residents of the HCPA.
      Intervention: The groups will be randomized to ezetimibe 10 mg for 5 days or placebo. On the
      fifth day, they should came after an overnight fast for blood tests collection [25(OH)D, PTH,
      calcium, albumin]. Next, all participants will receive orally a cholecalciferol 50,000 IU
      capsule and a snack containing 15g of fat. Participants will return 14 days after that for a
      second blood test.

      Statistical Analysis: Paired samples t-test or Wilcoxon signed rank-test will be used for
      comparing variables in two distinct moments (before cholecalciferol and 14 days after). The
      correlation between the numerical variables will be evaluated by the Spearman's correlation
      coefficient. A p value of less than 0.05 was considered statistically significant.

      Expected results: Differences between the serum levels of 25(OH)D in response to
      cholecalciferol plus ezetimibe compared to cholecalciferol plus placebo.

      Cost/benefit of the project: This is a low budget and minimal risks study that will
      contribute to a better understanding of the absorptive process of vitamin D and the effect of
      ezetimibe on its absorption.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: 25-hydroxyvitamin D
time frame: up to 24 months
description: The groups will be randomized to ezetimibe 10 mg for 5 days or placebo. On the fifth day, they should came after an overnight fast for blood tests collection [25(OH)D, PTH, calcium, albumin]. Next, all participants will receive orally a cholecalciferol 50,000 IU capsule and a snack containing 15g of fat. Participants will return 14 days after that for a second blood test.
arm group label: Placebo + Cholecalciferol
arm group type: Placebo Comparator
description: The groups will be randomized to ezetimibe or placebo. All participants will receive orally a cholecalciferol capsule.
arm group label: Ezetimibe + Cholecalciferol
arm group type: Active Comparator
description: The groups will be randomized to ezetimibe or placebo. All participants will receive orally a cholecalciferol capsule.
intervention type: Drug
intervention name: Ezetimibe
description: The groups will be randomized to ezetimibe 10 mg for 5 days or placebo. On the fifth day, they should came after an overnight fast for blood tests collection [25(OH)D, PTH, calcium, albumin]. Next, all participants will receive orally a cholecalciferol 50,000 IU capsule and a snack containing 15g of fat. Participants will return 14 days after that for a second blood test.
arm group label: Ezetimibe + Cholecalciferol
intervention type: Drug
intervention name: Cholecalciferol
description: All participants will receive orally a cholecalciferol 50,000 IU capsule and a snack containing 15g of fat. Participants will return 14 days after that for a second blood test.
arm group label: Ezetimibe + Cholecalciferol
arm group label: Placebo + Cholecalciferol
other name: Vitamin D
intervention type: Other
intervention name: Placebo
description: The groups will be randomized to ezetimibe 10 mg for 5 days or placebo. On the fifth day, they should came after an overnight fast for blood tests collection [25(OH)D, PTH, calcium, albumin]. Next, all participants will receive orally a cholecalciferol 50,000 IU capsule and a snack containing 15g of fat. Participants will return 14 days after that for a second blood test.
arm group label: Placebo + Cholecalciferol
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of Rio Grande do Sul
investigator full name: Mariana Costa Silva
investigator title: MD, MSc
mesh term: Vitamin D Deficiency
mesh term: Vitamin D
mesh term: Cholecalciferol
mesh term: Ezetimibe