<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/NCT03233295</url>
  </required_header>
  <id_info>
    <org_study_id>KDBON-CPI-01</org_study_id>
    <nct_id>NCT03233295</nct_id>
  </id_info>
  <brief_title>A Prospective, Single-centre, Open-label Study to Confirm the Efficacy and Safety of Vitamin D3 B.O.N. Intramuscular Injection in Adults With Vitamin D Deficiency</brief_title>
  <official_title>A Prospective, Single-centre, Open-label Study to Confirm the Efficacy and Safety of Vitamin D3 B.O.N. Intramuscular Injection in Adults With Vitamin D Deficiency</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kwang Dong Pharmaceutical co., ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kwang Dong Pharmaceutical co., ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Prospective, Single-centre, Open-label Study to Confirm the Efficacy and Safety of Vitamin&#xD;
      D3 B.O.N. Intramuscular Injection in adults with Vitamin D Deficiency&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 23, 2014</start_date>
  <completion_date type="Actual">August 27, 2016</completion_date>
  <primary_completion_date type="Actual">August 27, 2016</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>serum 25(OH)D concentration</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>serum 1,25(OH)2D concentration</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">108</enrollment>
  <condition>Vitamin D Deficiency</condition>
  <arm_group>
    <arm_group_label>Vitamin D deficiency</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vitamin D3 B.O.N. Injection</intervention_name>
    <description>cholecalciferol 200,000IU</description>
    <arm_group_label>Vitamin D deficiency</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with vitamin D deficiency&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who experienced a hypersensitivity to the cholecalciferol&#xD;
&#xD;
          -  Subjects with Hypercalcemia&#xD;
&#xD;
          -  Subjects with Hypercalciuria&#xD;
&#xD;
          -  Subjects with renal impairment&#xD;
&#xD;
          -  Subjects with calcium stone&#xD;
&#xD;
          -  Subjects diagnosed with sarcoidosis or pseudo-hypoparathyroidism&#xD;
&#xD;
          -  Subjects who are to take vitamin D supplements during the study period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>July 26, 2017</last_update_submitted>
  <last_update_submitted_qc>July 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03233295
org study id: KDBON-CPI-01
nct id: NCT03233295
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A Prospective, Single-centre, Open-label Study to Confirm the Efficacy and Safety of Vitamin
      D3 B.O.N. Intramuscular Injection in adults with Vitamin D Deficiency
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: serum 25(OH)D concentration
time frame: 12 months
measure: serum 1,25(OH)2D concentration
time frame: 12 months
arm group label: Vitamin D deficiency
arm group type: Experimental
intervention type: Drug
intervention name: Vitamin D3 B.O.N. Injection
description: cholecalciferol 200,000IU
arm group label: Vitamin D deficiency
criteria: 
gender: All
minimum age: 19 Years
maximum age: 65 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Vitamin D Deficiency
mesh term: Vitamin D
mesh term: Cholecalciferol
sharing ipd: No