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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014