<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/NCT03819452</url>
  </required_header>
  <id_info>
    <org_study_id>Fleifel002</org_study_id>
    <nct_id>NCT03819452</nct_id>
  </id_info>
  <brief_title>Impact of Vitamin D on Acute Ischemic Stroke Prognosis</brief_title>
  <acronym>IVASTO</acronym>
  <official_title>Impact of Vitamin D on Acute Ischemic Stroke Prognosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abha International Private Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Abha International Private Hospital</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>
      This is a registry for all patients admitted to hospital settings with Ischemic stroke in&#xD;
      Mansoura University Hospital. The registry will capture patients' data, investigations and&#xD;
      vitamin D level on admission. Follow-up is taking place using MODIFIED RANKIN SCALE&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2018</start_date>
  <completion_date type="Actual">January 25, 2019</completion_date>
  <primary_completion_date type="Actual">January 25, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>2 Days</target_duration>
  <primary_outcome>
    <measure>Correlation of Vitamin D level and the Incidence of Ischemic Stroke</measure>
    <time_frame>On admission</time_frame>
    <description>Correlation Analyses between vitamin D and ischemic stroke will be applies</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>impact of vitamin D on ischemic stroke in relationship with gender</measure>
    <time_frame>On admission</time_frame>
    <description>subgroup analyses per gender will be applied to check the difference of vitamin D</description>
  </secondary_outcome>
  <enrollment type="Actual">59</enrollment>
  <condition>Ischemic Stroke</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Vitamin D Level</intervention_name>
    <description>Vitamin D level is measured upon the presentation of the case with ischemic stroke</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients attending to hospital settings diagnosed with ischemic stroke are investigated to&#xD;
        have low level of vitamin D&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly diagnosed ischemic stroke not older than 48 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ischemic stroke due to accidents or any trauma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohamed FLeifel, MD PhD</last_name>
    <role>Study Director</role>
    <affiliation>Abha International Private Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mansoura University</name>
      <address>
        <city>Mansourah</city>
        <state>Dakahlia</state>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IQVIA</name>
      <address>
        <city>Basel</city>
        <zip>7415</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>January 25, 2019</last_update_submitted>
  <last_update_submitted_qc>January 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>vitamin D</keyword>
  <keyword>Ischemic Stroke</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Cerebral Infarction</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data of study participants will be kept confidential and no intention for distribution.</ipd_description>
  </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/NCT03819452
org study id: Fleifel002
nct id: NCT03819452
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a registry for all patients admitted to hospital settings with Ischemic stroke in
      Mansoura University Hospital. The registry will capture patients' data, investigations and
      vitamin D level on admission. Follow-up is taking place using MODIFIED RANKIN SCALE
observational model: Cohort
time perspective: Cross-Sectional
measure: Correlation of Vitamin D level and the Incidence of Ischemic Stroke
time frame: On admission
description: Correlation Analyses between vitamin D and ischemic stroke will be applies
measure: impact of vitamin D on ischemic stroke in relationship with gender
time frame: On admission
description: subgroup analyses per gender will be applied to check the difference of vitamin D
intervention type: Diagnostic Test
intervention name: Vitamin D Level
description: Vitamin D level is measured upon the presentation of the case with ischemic stroke
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Mohamed FLeifel, MD PhD
role: Study Director
affiliation: Abha International Private Hospital
facility: 
facility: 
country: Egypt
country: Switzerland
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Cerebral Infarction
mesh term: Ischemia
mesh term: Vitamin D
sharing ipd: No
ipd description: Data of study participants will be kept confidential and no intention for distribution.