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Omega-3 Fatty Acids in Autism Spectrum Disorders

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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

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorders Dietary Supplement: Omega-3 fatty acids Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Role of Omega-3 Fatty Acids in the Management of Singaporean Children With Autism Spectrum Disorders
Study Start Date : September 2011
Primary Completion Date : January 2013
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Omega-3 Fatty Acids
15ml omega-3 liquid form, twice a day for 12 weeks (Total daily dosage:840mg DHA and 192mg EPA)
Dietary Supplement: Omega-3 fatty acids



Primary Outcome Measures :
  1. Change from baseline in parent rated Social Responsiveness Scale (SRS) scores during treatment [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in parent rated Child Behavior Checklist (CBCL) scores during treatment [ Time Frame: 12 weeks ]
  2. Change from baseline in teacher rated Teacher Report (TRF) scores during treatment [ Time Frame: 12 weeks ]
  3. Change from baseline in teacher rated Social Responsiveness Scale (SRS) scores during treatment [ Time Frame: 12 weeks ]
  4. Change from baseline in clinician rated Clinical Global Impression (Severity and Improvements) scores during treatment [ Time Frame: 12 weeks ]
  5. Change from baseline in clinician rated Global Assessment of Functioning (GAF) scores during treatment [ Time Frame: 12 weeks ]
  6. Children's Yale-Brown Obsessive Compulsive Scale modified for Pervasive Developmental Disorders (CYBOCS-PDD) [ Time Frame: 12 weeks ]

Other Outcome Measures:
  1. Assessment of plasma fatty acid composition, measurements of DHA and EPA (components of omega-3), and total phospholipid count [ Time Frame: 12 weeks ]
  2. Assessment of dietary intake and nutritional intake of the child [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01695200


Locations
Singapore
Institute of Mental Health
Singapore, Singapore, 168937
Sponsors and Collaborators
National Healthcare Group, Singapore
Investigators
Principal Investigator: Min Sung, MBBS, MMed National Healthcare Group, Singapore

Responsible Party: Dr. Sung Min, Senior Consultant, National Healthcare Group, Singapore
ClinicalTrials.gov Identifier: NCT01695200     History of Changes
Other Study ID Numbers: DSRB: 2011/00028
First Posted: September 27, 2012    Key Record Dates
Last Update Posted: May 1, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders