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Omega-3 Fatty Acids in Autism Spectrum Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01695200
Recruitment Status : Completed
First Posted : September 27, 2012
Last Update Posted : May 1, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. Sung Min, National Healthcare Group, Singapore

Tracking Information
First Submitted Date  ICMJE September 21, 2012
First Posted Date  ICMJE September 27, 2012
Last Update Posted Date May 1, 2013
Study Start Date  ICMJE September 2011
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2012)
Change from baseline in parent rated Social Responsiveness Scale (SRS) scores during treatment [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2012)
  • Change from baseline in parent rated Child Behavior Checklist (CBCL) scores during treatment [ Time Frame: 12 weeks ]
  • Change from baseline in teacher rated Teacher Report (TRF) scores during treatment [ Time Frame: 12 weeks ]
  • Change from baseline in teacher rated Social Responsiveness Scale (SRS) scores during treatment [ Time Frame: 12 weeks ]
  • Change from baseline in clinician rated Clinical Global Impression (Severity and Improvements) scores during treatment [ Time Frame: 12 weeks ]
  • Change from baseline in clinician rated Global Assessment of Functioning (GAF) scores during treatment [ Time Frame: 12 weeks ]
  • Children's Yale-Brown Obsessive Compulsive Scale modified for Pervasive Developmental Disorders (CYBOCS-PDD) [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 25, 2012)
  • Assessment of plasma fatty acid composition, measurements of DHA and EPA (components of omega-3), and total phospholipid count [ Time Frame: 12 weeks ]
  • Assessment of dietary intake and nutritional intake of the child [ Time Frame: 12 weeks ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Omega-3 Fatty Acids in Autism Spectrum Disorders
Official Title  ICMJE The Role of Omega-3 Fatty Acids in the Management of Singaporean Children With Autism Spectrum Disorders
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Autism Spectrum Disorders
Intervention  ICMJE Dietary Supplement: Omega-3 fatty acids
Study Arms  ICMJE Experimental: Omega-3 Fatty Acids
15ml omega-3 liquid form, twice a day for 12 weeks (Total daily dosage:840mg DHA and 192mg EPA)
Intervention: Dietary Supplement: Omega-3 fatty acids
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 25, 2012)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Between ages 5 and 18 years old
  • Diagnosed to have Autism, Asperger Syndrome, or PDDNOS by the DSM-IV criteria; met the Autism or Spectrum classification for Autism Diagnostic Interview - Revised (ADI-R) and Autism Diagnostic Observation Schedule (ADOS)
  • Written parental consent for participation
  • Those not on current standard-of-care treatments for ASD

Exclusion Criteria:

  • Below 5 and above 18 years old
  • No formal diagnosis of Autism, Asperger Syndrome or PDD-NOS
  • Without written parental consent for participation
  • Those with brain pathology such as serious head injury, epilepsy, etc.
  • Those on current standard-of-care treatment for ASD
  • Those with psychotic symptoms, self-injurious behaviours and/or suicidal tendency, and other history of clinically significant medical conditions screened by the attending doctor to have increase the risk associated with study participation
  • Those on other types of medication or supplements or with change in dose
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01695200
Other Study ID Numbers  ICMJE DSRB: 2011/00028
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Sung Min, National Healthcare Group, Singapore
Study Sponsor  ICMJE National Healthcare Group, Singapore
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Min Sung, MBBS, MMed National Healthcare Group, Singapore
PRS Account National Healthcare Group, Singapore
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP