Omega-3 Fatty Acids in Autism Spectrum Disorders

Phase 4

Completed

• Conditions: Autism Spectrum Disorders
• Interventions: Dietary Supplement: Omega-3 fatty acids

• Registration Number: NCT01695200
• Lead Sponsor: National Healthcare Group, Singapore

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-09-21
• Study First Submitted QC: 2012-09-25
• Study First Posted: 2012-09-27
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-30
• Last Update Posted: 2013-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Omega-3 Fatty Acids	Omega-3 fatty acids	15ml omega-3 liquid form, twice a day for 12 weeks (Total daily dosage:840mg DHA and 192mg EPA)

Primary Outcome Measures

Name	Time	Method
Change from baseline in parent rated Social Responsiveness Scale (SRS) scores during treatment	12 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in parent rated Child Behavior Checklist (CBCL) 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 teacher rated Social Responsiveness Scale (SRS) scores during treatment	12 weeks
Change from baseline in teacher rated Teacher Report (TRF) 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

Trial Locations

Locations (1)

Institute of Mental Health; 🇸🇬 Singapore, Singapore