<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/NCT03228862</url>
  </required_header>
  <id_info>
    <org_study_id>088/60</org_study_id>
    <nct_id>NCT03228862</nct_id>
  </id_info>
  <brief_title>Optimal Doses of Ergocalciferol Supplementation for Treatment of Hypovitaminosis D in Adults</brief_title>
  <official_title>Optimal Initial and Maintenance Doses of Ergocalciferol Supplementation for Treatment of Hypovitaminosis D in Thai Adults: A Randomized, Double-blinded Dose-comparison Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chulalongkorn University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chulalongkorn University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      To investigate the optimal initial and maintenance doses of vitamin D2 supplementation for&#xD;
      the treatment of vitamin D insufficiency in Thai adults, and to determine the prevalence of&#xD;
      and risk factors for hypovitaminosis D among Thai adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A double-blinded prospective, randomized study undertaken at outpatient clinic of King&#xD;
      Chulalongkorn Memorial Hospital. The patients with vitamin D insufficiency were included and&#xD;
      divided into three groups according to their initial 25OHD concentrations. Patients are&#xD;
      randomly assigned to receive vitamin D2 40000, 60000 or 80000 IU once weekly. Serum 25(OH)D&#xD;
      levels are measured at 12 weeks after vitamin D2 supplemetaiton. The patients with 25OHD more&#xD;
      than 30ng/mL are enroll into the maintenance phase of the study and are randomly assigned to&#xD;
      receive vitamin D2 20000 or 40000 IU once weekly for another 12 months. The 25OHD&#xD;
      concentration are measure again at the end of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Anticipated">February 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2018</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>serum 25OHD phase 1</measure>
    <time_frame>12 weeks</time_frame>
    <description>serum 25OHD concentration after initial vitamin D2 supplemetaiton</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">360</enrollment>
  <condition>Vitamin D2 Supplementation in Vitamin D Insufficiency</condition>
  <arm_group>
    <arm_group_label>D40000</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients are randomly assigned to receive Ergocalciferol 40000 IU once weekly</description>
  </arm_group>
  <arm_group>
    <arm_group_label>D60000</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients are randomly assigned to receive Ergocalciferol 60000 IU once weekly</description>
  </arm_group>
  <arm_group>
    <arm_group_label>D80000</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients are randomly assigned to receive Ergocalciferol 80000 IU once weekly</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ergocalciferol</intervention_name>
    <description>Ergocalciferol 40000, 60000 and 80000 once weekly</description>
    <arm_group_label>D40000</arm_group_label>
    <arm_group_label>D60000</arm_group_label>
    <arm_group_label>D80000</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult age ≥ 15 years&#xD;
&#xD;
          2. BMI 18 - 35 kg/m2&#xD;
&#xD;
          3. Serum 25(OH)D &lt; 30ng/ml&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hypercalcemia, nephrolithiasis, or fractures&#xD;
&#xD;
          2. Hepatic disease&#xD;
&#xD;
          3. Kidney disease&#xD;
&#xD;
          4. Granulomatous disease&#xD;
&#xD;
          5. Currently supplemented with vitamin D&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chulalongkorn Univerity and King Chulalongkorn Memorial Hospital</name>
      <address>
        <city>Bangkok</city>
        <zip>13310</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>July 24, 2017</last_update_submitted>
  <last_update_submitted_qc>July 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chulalongkorn University</investigator_affiliation>
    <investigator_full_name>Lalita Wattanachanya, MD</investigator_full_name>
    <investigator_title>Assist Prof.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rickets</mesh_term>
    <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>Ergocalciferols</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/NCT03228862
org study id: 088/60
nct id: NCT03228862
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To investigate the optimal initial and maintenance doses of vitamin D2 supplementation for
      the treatment of vitamin D insufficiency in Thai adults, and to determine the prevalence of
      and risk factors for hypovitaminosis D among Thai adults.
A double-blinded prospective, randomized study undertaken at outpatient clinic of King
      Chulalongkorn Memorial Hospital. The patients with vitamin D insufficiency were included and
      divided into three groups according to their initial 25OHD concentrations. Patients are
      randomly assigned to receive vitamin D2 40000, 60000 or 80000 IU once weekly. Serum 25(OH)D
      levels are measured at 12 weeks after vitamin D2 supplemetaiton. The patients with 25OHD more
      than 30ng/mL are enroll into the maintenance phase of the study and are randomly assigned to
      receive vitamin D2 20000 or 40000 IU once weekly for another 12 months. The 25OHD
      concentration are measure again at the end of the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: serum 25OHD phase 1
time frame: 12 weeks
description: serum 25OHD concentration after initial vitamin D2 supplemetaiton
arm group label: D40000
arm group type: Experimental
description: Patients are randomly assigned to receive Ergocalciferol 40000 IU once weekly
arm group label: D60000
arm group type: Experimental
description: Patients are randomly assigned to receive Ergocalciferol 60000 IU once weekly
arm group label: D80000
arm group type: Experimental
description: Patients are randomly assigned to receive Ergocalciferol 80000 IU once weekly
intervention type: Drug
intervention name: Ergocalciferol
description: Ergocalciferol 40000, 60000 and 80000 once weekly
arm group label: D40000
arm group label: D60000
arm group label: D80000
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Chulalongkorn University
investigator full name: Lalita Wattanachanya, MD
investigator title: Assist Prof.
mesh term: Rickets
mesh term: Avitaminosis
mesh term: Vitamin D Deficiency
mesh term: Ergocalciferols
mesh term: Vitamin D