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Omega-3 Fatty Acids in Autism Spectrum Disorders

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Sung Min, National Healthcare Group, Singapore
ClinicalTrials.gov Identifier:
NCT01695200
First received: September 21, 2012
Last updated: April 30, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention Phase
Autism Spectrum Disorders
 Dietary Supplement: Omega-3 fatty acids
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Role of Omega-3 Fatty Acids in the Management of Singaporean Children With Autism Spectrum Disorders

Resource links provided by NLM:

MedlinePlus related topics: Autism
U.S. FDA Resources

Further study details as provided by National Healthcare Group, Singapore:

Primary Outcome Measures:
  • Change from baseline in parent rated Social Responsiveness Scale (SRS) scores during treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in parent rated Child Behavior Checklist (CBCL) scores during treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in teacher rated Teacher Report (TRF) scores during treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in teacher rated Social Responsiveness Scale (SRS) scores during treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in clinician rated Clinical Global Impression (Severity and Improvements) scores during treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in clinician rated Global Assessment of Functioning (GAF) scores during treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Children's Yale-Brown Obsessive Compulsive Scale modified for Pervasive Developmental Disorders (CYBOCS-PDD) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Assessment of plasma fatty acid composition, measurements of DHA and EPA (components of omega-3), and total phospholipid count [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Assessment of dietary intake and nutritional intake of the child [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: September 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: September 21, 2012
Last Updated: April 30, 2013
Health Authority: Singapore: Health Sciences Authority

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013