Clinical trial NCT01695200: Omega-3 Fatty Acids in Autism Spectrum Disorders
Official title: The Role of Omega-3 Fatty Acids in the Management of Singaporean Children With Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Autism Spectrum Disorders
Lead sponsor: National Healthcare Group, Singapore
Sponsor class: OTHER_GOV
First posted: 2012-09-27
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change from baseline in parent rated Social Responsiveness Scale (SRS) scores during treatment
timeFrame: 12 weeks
Secondary outcomes:
measure: Change from baseline in parent rated Child Behavior Checklist (CBCL) scores during treatment
timeFrame: 12 weeks
measure: Change from baseline in teacher rated Teacher Report (TRF) scores during treatment
timeFrame: 12 weeks
measure: Change from baseline in teacher rated Social Responsiveness Scale (SRS) scores during treatment
timeFrame: 12 weeks
measure: Change from baseline in clinician rated Clinical Global Impression (Severity and Improvements) scores during treatment
timeFrame: 12 weeks
measure: Change from baseline in clinician rated Global Assessment of Functioning (GAF) scores during treatment
timeFrame: 12 weeks
measure: Children's Yale-Brown Obsessive Compulsive Scale modified for Pervasive Developmental Disorders (CYBOCS-PDD)
timeFrame: 12 weeks
Other outcomes:
measure: Assessment of plasma fatty acid composition, measurements of DHA and EPA (components of omega-3), and total phospholipid count
timeFrame: 12 weeks
measure: Assessment of dietary intake and nutritional intake of the child
timeFrame: 12 weeks
Locations:
city: Singapore
country: Singapore
facility: Institute of Mental Health
Study officials:
affiliation: National Healthcare Group, Singapore
name: Min Sung, MBBS, MMed
role: PRINCIPAL_INVESTIGATOR
References: