Omega-3 Fatty Acids in Autism Spectrum Disorders

Study Overview
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Brief Summary
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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.

Official Title
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The Role of Omega-3 Fatty Acids in the Management of Singaporean Children With Autism Spectrum Disorders

Conditions
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Autism Spectrum Disorders

Intervention / Treatment
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* Dietary Supplement: Omega-3 fatty acids


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omega-3 Fatty Acids<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in parent rated Social Responsiveness Scale (SRS) scores during treatment |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 Clinical Global Impression (Severity and Improvements) 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 |