<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/NCT03284294</url>
  </required_header>
  <id_info>
    <org_study_id>PS-201709.01</org_study_id>
    <nct_id>NCT03284294</nct_id>
  </id_info>
  <brief_title>Influence of Vitamin D Supplementation on Serum BDNF Level and Cognitive Function in Schizophrenia</brief_title>
  <official_title>The Influence of Vitamin D Supplementation on Serum Brain Derived Neurotrophic Factor Level and Cognitive Function in Schizophrenia Treated With Atypical Antipsychotic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitas Padjadjaran</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitas Padjadjaran</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the study is to evaluate the influence of vitamin D supplementation on Serum&#xD;
      Brain Derived Neurotrophic Factor level and cognitive function in schizophrenia treated with&#xD;
      atypical antipsychotic. Methods: The investigator will use randomized controlled trial&#xD;
      design. 40 chronic schizophrenia patients with vitamin D insufficiency or deficiency treated&#xD;
      with atypical antipsychotic, will be randomly assign (1:1 ratio) to receive either daily oral&#xD;
      cholecalciferol 2000 IU or placebo for 8 weeks. Assessment of BDNF serum and cognitive&#xD;
      function will be performed at baseline and after 8 weeks period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">April 15, 2020</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">August 2020</primary_completion_date>
  <phase>Phase 3</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>
    <intervention_model_description>Randomized Controlled Trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cognitive Function</measure>
    <time_frame>At the end of week 8</time_frame>
    <description>cognitive function as measured with standard cognitive battery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BDNF serum level</measure>
    <time_frame>At the end of week 8</time_frame>
    <description>BDNF serum level as measured with ELISA method</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Oral placebo daily for 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vitamin D</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Vitamin D Cholecalciferol 2000 IU oral daily for 8 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cholecalciferol</intervention_name>
    <description>cholecalciferol 2000 IU oral daily for 8 weeks</description>
    <arm_group_label>Vitamin D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Oral placebo daily for 8 weeks</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic schizophrenia&#xD;
&#xD;
          -  Serum 25(OH)D level below 30 ng/ml&#xD;
&#xD;
          -  Deficit in cognitive functions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypercalcemia&#xD;
&#xD;
          -  Hepatic or renal failure&#xD;
&#xD;
          -  Obese&#xD;
&#xD;
          -  Metabolic syndrome&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Tuti Kurnianingsih, MD</last_name>
    <phone>+62 812 232 9249</phone>
    <email>kurniatuti@gmail.com</email>
  </overall_contact>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>March 31, 2020</last_update_submitted>
  <last_update_submitted_qc>March 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitas Padjadjaran</investigator_affiliation>
    <investigator_full_name>Tuti Kurnianingsih</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</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>
  <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/NCT03284294
org study id: PS-201709.01
nct id: NCT03284294
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The objective of the study is to evaluate the influence of vitamin D supplementation on Serum
      Brain Derived Neurotrophic Factor level and cognitive function in schizophrenia treated with
      atypical antipsychotic. Methods: The investigator will use randomized controlled trial
      design. 40 chronic schizophrenia patients with vitamin D insufficiency or deficiency treated
      with atypical antipsychotic, will be randomly assign (1:1 ratio) to receive either daily oral
      cholecalciferol 2000 IU or placebo for 8 weeks. Assessment of BDNF serum and cognitive
      function will be performed at baseline and after 8 weeks period.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized Controlled Trial
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Cognitive Function
time frame: At the end of week 8
description: cognitive function as measured with standard cognitive battery
measure: BDNF serum level
time frame: At the end of week 8
description: BDNF serum level as measured with ELISA method
arm group label: Placebo
arm group type: Placebo Comparator
description: Oral placebo daily for 8 weeks
arm group label: Vitamin D
arm group type: Active Comparator
description: Vitamin D Cholecalciferol 2000 IU oral daily for 8 weeks
intervention type: Drug
intervention name: Cholecalciferol
description: cholecalciferol 2000 IU oral daily for 8 weeks
arm group label: Vitamin D
intervention type: Drug
intervention name: Placebo
description: Oral placebo daily for 8 weeks
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Tuti Kurnianingsih, MD
phone: +62 812 232 9249
email: kurniatuti@gmail.com
responsible party type: Principal Investigator
investigator affiliation: Universitas Padjadjaran
investigator full name: Tuti Kurnianingsih
investigator title: Principal Investigator
mesh term: Schizophrenia
mesh term: Cholecalciferol
mesh term: Vitamin D
sharing ipd: No