Autism Spectrum Disorders
Conditions
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.
Interventions
DIETARY_SUPPLEMENTOmega-3 fatty acids
Sponsors
National Healthcare Group, Singapore
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in parent rated Social Responsiveness Scale (SRS) scores during treatment | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in parent rated Child Behavior Checklist (CBCL) scores during treatment | 12 weeks |
| Change from baseline in teacher rated Teacher Report (TRF) scores during treatment | 12 weeks |
| Change from baseline in teacher rated Social Responsiveness Scale (SRS) scores during treatment | 12 weeks |
| Change from baseline in clinician rated Global Assessment of Functioning (GAF) scores during treatment | 12 weeks |
| Children's Yale-Brown Obsessive Compulsive Scale modified for Pervasive Developmental Disorders (CYBOCS-PDD) | 12 weeks |
| Change from baseline in clinician rated Clinical Global Impression (Severity and Improvements) scores during treatment | 12 weeks |
Other
| Measure | Time frame |
|---|---|
| Assessment of plasma fatty acid composition, measurements of DHA and EPA (components of omega-3), and total phospholipid count | 12 weeks |
| Assessment of dietary intake and nutritional intake of the child | 12 weeks |
Countries
Singapore
Outcome results
None listed