<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/NCT02222311</url>
  </required_header>
  <id_info>
    <org_study_id>0038-14-HYMC</org_study_id>
    <nct_id>NCT02222311</nct_id>
  </id_info>
  <brief_title>Influence of Vitamin D Deficiency on the Development of Autism</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hillel Yaffe Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hillel Yaffe Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators wish to study the effect of Vitamin D on the development of autism in&#xD;
      children. The investigators will also investigate the environmental and genetic influences on&#xD;
      the level of Vitamin D in children with autism.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2014</start_date>
  <completion_date type="Anticipated">April 2018</completion_date>
  <primary_completion_date type="Anticipated">November 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Level of Vitamin D</measure>
    <time_frame>One day</time_frame>
    <description>Blood samples of patients with and without autism with be taken and the level of vitamin D in their serum will be determined (international units).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect of environment on Vitamin D level</measure>
    <time_frame>One week</time_frame>
    <description>All participant blood samples will be measured for levels of oxidative stress markers and antioxidants.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Autism</condition>
  <arm_group>
    <arm_group_label>Autistic Children</arm_group_label>
    <description>Children diagnosed with autism spectrum disorder according to the criteria of the Diagnostic Statistical Manual-V will have blood samples taken for laboratory analysis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Children</arm_group_label>
    <description>Children with no developmental or physical diseases will have blood samples taken for laboratory analysis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Children with Attention Deficit Disorder</arm_group_label>
    <description>Blood samples from children with Attention Deficit Disorder will be measured for Vitamin D and oxidative stress markers.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood Samples</intervention_name>
    <arm_group_label>Autistic Children</arm_group_label>
    <arm_group_label>Children with Attention Deficit Disorder</arm_group_label>
    <arm_group_label>Healthy Children</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children with autism who have presented to the Child Development Institute at the Hillel&#xD;
        Yaffe Medical Center and from pediatric neurology community clinics. The control groups&#xD;
        include healthy age-matched children and children with Attention Deficit Disorder (ADD) who&#xD;
        have presented to the Child Development Institute at the Hillel Yaffe Medical Center and&#xD;
        from pediatric neurology community clinics.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Autistic children&#xD;
&#xD;
          -  Healthy children&#xD;
&#xD;
          -  Children with ADD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All others&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Muhammad Mahajnah, MD, PhD</last_name>
    <phone>972-5-624-6959</phone>
    <email>mohamedm@hy.health.gov.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hillel Yaffe Medical Center</name>
      <address>
        <city>Hadera</city>
        <zip>38100</zip>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Muhammad Mahajnah, MD, PhD</last_name>
      <phone>972-5-624-6959</phone>
      <email>mohamedm@hy.health.gov.il</email>
    </contact>
    <investigator>
      <last_name>Muhammad Mahajnah, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>August 20, 2014</last_update_submitted>
  <last_update_submitted_qc>August 20, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 21, 2014</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>Autistic Disorder</mesh_term>
  </condition_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/NCT02222311
org study id: 0038-14-HYMC
nct id: NCT02222311
lead sponsor: 
has dmc: Yes
The investigators wish to study the effect of Vitamin D on the development of autism in
      children. The investigators will also investigate the environmental and genetic influences on
      the level of Vitamin D in children with autism.
observational model: Case-Control
time perspective: Prospective
measure: Level of Vitamin D
time frame: One day
description: Blood samples of patients with and without autism with be taken and the level of vitamin D in their serum will be determined (international units).
measure: Effect of environment on Vitamin D level
time frame: One week
description: All participant blood samples will be measured for levels of oxidative stress markers and antioxidants.
arm group label: Autistic Children
description: Children diagnosed with autism spectrum disorder according to the criteria of the Diagnostic Statistical Manual-V will have blood samples taken for laboratory analysis.
arm group label: Healthy Children
description: Children with no developmental or physical diseases will have blood samples taken for laboratory analysis.
arm group label: Children with Attention Deficit Disorder
description: Blood samples from children with Attention Deficit Disorder will be measured for Vitamin D and oxidative stress markers.
intervention type: Other
intervention name: Blood Samples
arm group label: Autistic Children
arm group label: Children with Attention Deficit Disorder
arm group label: Healthy Children
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Muhammad Mahajnah, MD, PhD
phone: 972-5-624-6959
email: mohamedm@hy.health.gov.il
facility: 
contact: 
investigator: 
country: Israel
responsible party type: Sponsor
mesh term: Autistic Disorder