<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/NCT01695200</url>
  </required_header>
  <id_info>
    <org_study_id>DSRB: 2011/00028</org_study_id>
    <nct_id>NCT01695200</nct_id>
  </id_info>
  <brief_title>Omega-3 Fatty Acids in Autism Spectrum Disorders</brief_title>
  <official_title>The Role of Omega-3 Fatty Acids in the Management of Singaporean Children With Autism Spectrum Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Healthcare Group, Singapore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Healthcare Group, Singapore</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a 12-week open label trial to evaluate whether omega-3 fatty acids is effective in&#xD;
      reducing the severity of autism and its comorbidities.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in parent rated Social Responsiveness Scale (SRS) scores during treatment</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in parent rated Child Behavior Checklist (CBCL) scores during treatment</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in teacher rated Teacher Report (TRF) scores during treatment</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in teacher rated Social Responsiveness Scale (SRS) scores during treatment</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in clinician rated Clinical Global Impression (Severity and Improvements) scores during treatment</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in clinician rated Global Assessment of Functioning (GAF) scores during treatment</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Children's Yale-Brown Obsessive Compulsive Scale modified for Pervasive Developmental Disorders (CYBOCS-PDD)</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Assessment of plasma fatty acid composition, measurements of DHA and EPA (components of omega-3), and total phospholipid count</measure>
    <time_frame>12 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Assessment of dietary intake and nutritional intake of the child</measure>
    <time_frame>12 weeks</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Autism Spectrum Disorders</condition>
  <arm_group>
    <arm_group_label>Omega-3 Fatty Acids</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>15ml omega-3 liquid form, twice a day for 12 weeks (Total daily dosage:840mg DHA and 192mg EPA)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Omega-3 fatty acids</intervention_name>
    <arm_group_label>Omega-3 Fatty Acids</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between ages 5 and 18 years old&#xD;
&#xD;
          -  Diagnosed to have Autism, Asperger Syndrome, or PDDNOS by the DSM-IV criteria; met the&#xD;
             Autism or Spectrum classification for Autism Diagnostic Interview - Revised (ADI-R)&#xD;
             and Autism Diagnostic Observation Schedule (ADOS)&#xD;
&#xD;
          -  Written parental consent for participation&#xD;
&#xD;
          -  Those not on current standard-of-care treatments for ASD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Below 5 and above 18 years old&#xD;
&#xD;
          -  No formal diagnosis of Autism, Asperger Syndrome or PDD-NOS&#xD;
&#xD;
          -  Without written parental consent for participation&#xD;
&#xD;
          -  Those with brain pathology such as serious head injury, epilepsy, etc.&#xD;
&#xD;
          -  Those on current standard-of-care treatment for ASD&#xD;
&#xD;
          -  Those with psychotic symptoms, self-injurious behaviours and/or suicidal tendency, and&#xD;
             other history of clinically significant medical conditions screened by the attending&#xD;
             doctor to have increase the risk associated with study participation&#xD;
&#xD;
          -  Those on other types of medication or supplements or with change in dose&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Min Sung, MBBS, MMed</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Healthcare Group, Singapore</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute of Mental Health</name>
      <address>
        <city>Singapore</city>
        <zip>168937</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>April 2013</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>April 30, 2013</last_update_submitted>
  <last_update_submitted_qc>April 30, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 1, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Healthcare Group, Singapore</investigator_affiliation>
    <investigator_full_name>Dr. Sung Min</investigator_full_name>
    <investigator_title>Senior Consultant</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autistic Disorder</mesh_term>
    <mesh_term>Autism Spectrum Disorder</mesh_term>
    <mesh_term>Child Development Disorders, Pervasive</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/NCT01695200
org study id: DSRB: 2011/00028
nct id: NCT01695200
lead sponsor: 
has dmc: No
This is a 12-week open label trial to evaluate whether omega-3 fatty acids is effective in
      reducing the severity of autism and its comorbidities.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline in parent rated Social Responsiveness Scale (SRS) scores during treatment
time frame: 12 weeks
measure: Change from baseline in parent rated Child Behavior Checklist (CBCL) scores during treatment
time frame: 12 weeks
measure: Change from baseline in teacher rated Teacher Report (TRF) scores during treatment
time frame: 12 weeks
measure: Change from baseline in teacher rated Social Responsiveness Scale (SRS) scores during treatment
time frame: 12 weeks
measure: Change from baseline in clinician rated Clinical Global Impression (Severity and Improvements) scores during treatment
time frame: 12 weeks
measure: Change from baseline in clinician rated Global Assessment of Functioning (GAF) scores during treatment
time frame: 12 weeks
measure: Children's Yale-Brown Obsessive Compulsive Scale modified for Pervasive Developmental Disorders (CYBOCS-PDD)
time frame: 12 weeks
measure: Assessment of plasma fatty acid composition, measurements of DHA and EPA (components of omega-3), and total phospholipid count
time frame: 12 weeks
measure: Assessment of dietary intake and nutritional intake of the child
time frame: 12 weeks
arm group label: Omega-3 Fatty Acids
arm group type: Experimental
description: 15ml omega-3 liquid form, twice a day for 12 weeks (Total daily dosage:840mg DHA and 192mg EPA)
intervention type: Dietary Supplement
intervention name: Omega-3 fatty acids
arm group label: Omega-3 Fatty Acids
criteria: 
gender: All
minimum age: 5 Years
maximum age: 18 Years
healthy volunteers: No
last name: Min Sung, MBBS, MMed
role: Principal Investigator
affiliation: National Healthcare Group, Singapore
facility: 
country: Singapore
responsible party type: Principal Investigator
investigator affiliation: National Healthcare Group, Singapore
investigator full name: Dr. Sung Min
investigator title: Senior Consultant
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
mesh term: Child Development Disorders, Pervasive