<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/NCT02186106</url>
  </required_header>
  <id_info>
    <org_study_id>H-4-2011-094</org_study_id>
    <nct_id>NCT02186106</nct_id>
  </id_info>
  <brief_title>Dosage Calculation for Vitamin D Treatment</brief_title>
  <official_title>The Effect of Oral Loading Doses of Cholecalciferol on the Serum Concentration of 25-OH-vitamin-D</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bispebjerg Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bispebjerg Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Severe vitamin D deficiency can be treated with oral loading doses of cholecalciferol. Our&#xD;
      objective was to determine how to calculate the quantity of cholecalciferol needed for&#xD;
      supplementation by single algorithm, usable on a patient-to-patient basis.&#xD;
&#xD;
      We've conducted two studies. Study 1 was done retroactively and included 88 patients treated&#xD;
      for low vitamin D, 60 of those with a loading dose. The second study included 29 patients and&#xD;
      aimed to test the validity of an algorithm based on data from study 1, which included patient&#xD;
      BMI. Both studies used oral loading doses and daily supplementation of cholecalciferol.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in baseline value of [25-OH-vitamin-D]</measure>
    <time_frame>1 week, 3 weeks and 3 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Deficiency, Vitamin D</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Loading dose substitution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Substituted with a highdose of cholecalciferol at study start</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Historic controls</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control subjects from journal archive</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cholecalciferol</intervention_name>
    <arm_group_label>Loading dose substitution</arm_group_label>
    <other_name>Dekristol capsules of 20.000 IU pr. capsule</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  severe hypovitaminosis D (25OH-vit.D &lt;25 nmol/L)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Malabsorption&#xD;
&#xD;
          -  Renal disease&#xD;
&#xD;
          -  Other treatment with vitamin D related products&#xD;
&#xD;
          -  Patients with a recent travel history with suspected increased sun exposure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>July 7, 2014</last_update_submitted>
  <last_update_submitted_qc>July 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bispebjerg Hospital</investigator_affiliation>
    <investigator_full_name>Rasmus Bo Jansen</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Avitaminosis</mesh_term>
    <mesh_term>Vitamin D Deficiency</mesh_term>
  </condition_browse>
  <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/NCT02186106
org study id: H-4-2011-094
nct id: NCT02186106
lead sponsor: 
has dmc: No
Severe vitamin D deficiency can be treated with oral loading doses of cholecalciferol. Our
      objective was to determine how to calculate the quantity of cholecalciferol needed for
      supplementation by single algorithm, usable on a patient-to-patient basis.

      We've conducted two studies. Study 1 was done retroactively and included 88 patients treated
      for low vitamin D, 60 of those with a loading dose. The second study included 29 patients and
      aimed to test the validity of an algorithm based on data from study 1, which included patient
      BMI. Both studies used oral loading doses and daily supplementation of cholecalciferol.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in baseline value of [25-OH-vitamin-D]
time frame: 1 week, 3 weeks and 3 months
arm group label: Loading dose substitution
arm group type: Experimental
description: Substituted with a highdose of cholecalciferol at study start
arm group label: Historic controls
arm group type: No Intervention
description: Control subjects from journal archive
intervention type: Drug
intervention name: Cholecalciferol
arm group label: Loading dose substitution
other name: Dekristol capsules of 20.000 IU pr. capsule
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Bispebjerg Hospital
investigator full name: Rasmus Bo Jansen
investigator title: MD
mesh term: Avitaminosis
mesh term: Vitamin D Deficiency
mesh term: Cholecalciferol
mesh term: Vitamin D