<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/NCT01728987</url>
  </required_header>
  <id_info>
    <org_study_id>TromsøEndo-2012-1</org_study_id>
    <nct_id>NCT01728987</nct_id>
  </id_info>
  <brief_title>The Significance of Vitamin D Storage in Adipose Tissue</brief_title>
  <official_title>The Significance of Vitamin D Storage in Adipose Tissue</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Tromso</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Tromso</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will examine the role of adipose tissue in vitamin D physiology, particularly its&#xD;
      role as a depot. the study is randomized double blind and placebo controlled.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      vitamin d versus placebo will be given for 12 months. Biopsies will be taken at baseline and&#xD;
      every 6 month for 2 years. Blood samples will be collected every 6th month. the study will&#xD;
      thus give information on storage during vitamin d supplementation as well as use of vitamin d&#xD;
      fat stores after stopping vitamin D supplementation&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    study stopped due to Financial problems&#xD;
  </why_stopped>
  <start_date>August 2016</start_date>
  <completion_date type="Anticipated">February 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>Phase 2</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>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>vitamin D in adipose tissue biopsies</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>rate of decline of 25ohd in serum</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>cholecalciferol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>vitamin d (cholecalciferol) will be given as a capsule of 20.000 Iu twice a week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>the placebo capsules are looking identical to the vitamin d capsules and contain medium chain triglycerides and arachis oil</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>cholecalciferol</intervention_name>
    <description>as in arm description</description>
    <arm_group_label>cholecalciferol</arm_group_label>
    <other_name>Dekristol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>capsule looking identical to the cholecalciferol capsule</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy subjects&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  hypercalcemia&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  women without safe contraception&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>rolf jorde, professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Tromsø, Norway</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Tromsø</name>
      <address>
        <city>Tromsø</city>
        <zip>9037</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>September 3, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>November 14, 2016</last_update_submitted>
  <last_update_submitted_qc>November 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholecalciferol</mesh_term>
    <mesh_term>Vitamin D</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/NCT01728987
org study id: TromsøEndo-2012-1
nct id: NCT01728987
lead sponsor: 
has dmc: No
The study will examine the role of adipose tissue in vitamin D physiology, particularly its
      role as a depot. the study is randomized double blind and placebo controlled.
vitamin d versus placebo will be given for 12 months. Biopsies will be taken at baseline and
      every 6 month for 2 years. Blood samples will be collected every 6th month. the study will
      thus give information on storage during vitamin d supplementation as well as use of vitamin d
      fat stores after stopping vitamin D supplementation
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: vitamin D in adipose tissue biopsies
time frame: 12 months
measure: rate of decline of 25ohd in serum
time frame: 12 months
arm group label: cholecalciferol
arm group type: Active Comparator
description: vitamin d (cholecalciferol) will be given as a capsule of 20.000 Iu twice a week
arm group label: placebo
arm group type: Placebo Comparator
description: the placebo capsules are looking identical to the vitamin d capsules and contain medium chain triglycerides and arachis oil
intervention type: Drug
intervention name: cholecalciferol
description: as in arm description
arm group label: cholecalciferol
other name: Dekristol
intervention type: Drug
intervention name: placebo
description: capsule looking identical to the cholecalciferol capsule
arm group label: placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: rolf jorde, professor
role: Principal Investigator
affiliation: University of Tromsø, Norway
facility: 
country: Norway
responsible party type: Sponsor
mesh term: Cholecalciferol
mesh term: Vitamin D