<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/NCT03248544</url>
  </required_header>
  <id_info>
    <org_study_id>1396-607</org_study_id>
    <nct_id>NCT03248544</nct_id>
  </id_info>
  <brief_title>Therapeutic Benefit of Preoperative Supplemental Vitamin D in Patients Undergoing Brain Tumor Surgery</brief_title>
  <official_title>Effect of Single High Dose Vitamin D3 on Peri-operative and Post-operative Complications and Clinical Outcomes in Patients Under Craniotomy for Brain Tumor Resection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shahid Beheshti University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shahid Beheshti 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>
      Vitamin D supplementation not only has beneficial effects on morbidity and mortality in&#xD;
      critically ill patients but it may also lead to alleviate of seizure, brain edema, infection,&#xD;
      pain and some other perioperative complications, possibly in part through an attenuation of&#xD;
      the immune response.In this trial patients with brain tumor under craniotomy will receive a&#xD;
      single high dose vitamin D compared to control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized, double blind, controlled trial will be conducted in neurosurgery ward,&#xD;
      operating room (OR) and intensive care unit (ICU) in Tehran, Iran. After a full review of the&#xD;
      inclusion and exclusion criteria and explanation of the risks and benefits of the study,&#xD;
      written consent form will be completed. The participants are 60 eligible hospitalized&#xD;
      patients that diagnosed with brain tumor and need to craniotomy, aged ≥ 18 years.&#xD;
      Intervention patients will be received an intramuscular (IM) single dose of vitamin D (300000&#xD;
      IU). Patients will be evaluated for occurrence of perioperative complications and clinical&#xD;
      outcomes immediately after surgery until 1 month later and 1 and 6 months mortality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 6, 2017</start_date>
  <completion_date type="Actual">July 30, 2018</completion_date>
  <primary_completion_date type="Actual">July 30, 2018</primary_completion_date>
  <phase>N/A</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vitamin D level</measure>
    <time_frame>Postoperative day 5</time_frame>
    <description>25(OH) will be measured after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Peri-operative Complications</measure>
    <time_frame>During surgery, recovery and hospitalization (5 days post op)</time_frame>
    <description>Complications in operating room, recovery room, ICU and neurosurgery ward</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative Complications</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>Complications after hospital discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of stay in ICU</measure>
    <time_frame>30 days</time_frame>
    <description>Length of stay in ICU is measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of stay in hospital</measure>
    <time_frame>30 days</time_frame>
    <description>Length of stay in hospital is measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>1-month mortality</measure>
    <time_frame>30 days</time_frame>
    <description>Mortality during hospitalization or 1 month after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6-month mortality</measure>
    <time_frame>6 months</time_frame>
    <description>Mortality during 6 months after surgery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Brain Neoplasms</condition>
  <arm_group>
    <arm_group_label>vitamin D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention patients will be received a single dose of 300000 IU vitamin D via intramuscular injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Control patients will not be received any intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>vitamin D</intervention_name>
    <description>Fat-soluble vitamin D injection contain of 300,000 IU vitamin D that given via intramuscular injection</description>
    <arm_group_label>vitamin D</arm_group_label>
    <other_name>Cholecalciferol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>control</intervention_name>
    <description>No intervention</description>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent of patient or legal representative&#xD;
&#xD;
          -  25(OH)D level below 20ng/dL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other trial participation, including previous participation in the pilot trial&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Hypercalcemia&#xD;
&#xD;
          -  Hyperphosphatemia&#xD;
&#xD;
          -  Tuberculosis&#xD;
&#xD;
          -  Sarcoidosis&#xD;
&#xD;
          -  History of nephrolithiasis&#xD;
&#xD;
          -  History of hyperparathyroidis&#xD;
&#xD;
          -  Medications that interfere with vitamin D metabolism&#xD;
&#xD;
          -  Renal Insufficiency&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zahra Vahdat Shariatpanahi, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences</name>
      <address>
        <city>Tehran</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shohada Tajrish Hospital</name>
      <address>
        <city>Tehran</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>July 29, 2018</last_update_submitted>
  <last_update_submitted_qc>July 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shahid Beheshti University</investigator_affiliation>
    <investigator_full_name>Zahra Vahdat Shariatpanahi</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>vitamin D</keyword>
  <keyword>Brain Neoplasms</keyword>
  <keyword>perioperative complications</keyword>
  <keyword>clinical outcomes</keyword>
  <keyword>craniotomy</keyword>
  <keyword>Immune System</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Neoplasms</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>Undecided</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/NCT03248544
org study id: 1396-607
nct id: NCT03248544
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Vitamin D supplementation not only has beneficial effects on morbidity and mortality in
      critically ill patients but it may also lead to alleviate of seizure, brain edema, infection,
      pain and some other perioperative complications, possibly in part through an attenuation of
      the immune response.In this trial patients with brain tumor under craniotomy will receive a
      single high dose vitamin D compared to control group.
A randomized, double blind, controlled trial will be conducted in neurosurgery ward,
      operating room (OR) and intensive care unit (ICU) in Tehran, Iran. After a full review of the
      inclusion and exclusion criteria and explanation of the risks and benefits of the study,
      written consent form will be completed. The participants are 60 eligible hospitalized
      patients that diagnosed with brain tumor and need to craniotomy, aged ≥ 18 years.
      Intervention patients will be received an intramuscular (IM) single dose of vitamin D (300000
      IU). Patients will be evaluated for occurrence of perioperative complications and clinical
      outcomes immediately after surgery until 1 month later and 1 and 6 months mortality.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Vitamin D level
time frame: Postoperative day 5
description: 25(OH) will be measured after surgery
measure: Peri-operative Complications
time frame: During surgery, recovery and hospitalization (5 days post op)
description: Complications in operating room, recovery room, ICU and neurosurgery ward
measure: Post-operative Complications
time frame: 30 days after surgery
description: Complications after hospital discharge
measure: Duration of stay in ICU
time frame: 30 days
description: Length of stay in ICU is measured
measure: Duration of stay in hospital
time frame: 30 days
description: Length of stay in hospital is measured
measure: 1-month mortality
time frame: 30 days
description: Mortality during hospitalization or 1 month after surgery
measure: 6-month mortality
time frame: 6 months
description: Mortality during 6 months after surgery
arm group label: vitamin D
arm group type: Experimental
description: Intervention patients will be received a single dose of 300000 IU vitamin D via intramuscular injection
arm group label: control
arm group type: Other
description: Control patients will not be received any intervention
intervention type: Drug
intervention name: vitamin D
description: Fat-soluble vitamin D injection contain of 300,000 IU vitamin D that given via intramuscular injection
arm group label: vitamin D
other name: Cholecalciferol
intervention type: Other
intervention name: control
description: No intervention
arm group label: control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Zahra Vahdat Shariatpanahi, MD, PhD
role: Study Chair
affiliation: Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran
facility: 
facility: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Shahid Beheshti University
investigator full name: Zahra Vahdat Shariatpanahi
investigator title: Associate Professor
mesh term: Brain Neoplasms
mesh term: Vitamin D
mesh term: Cholecalciferol
sharing ipd: Undecided