Omega-3 Fatty Acids in Autism Spectrum Disorders

Autism Spectrum Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01695200
• Other study ID #: DSRB: 2011/00028
• Status: Completed
• Phase: Phase 4
• First received: September 21, 2012
• Last updated: April 30, 2013
• Start date: September 2011
• Est. completion date: January 2013

Study information

• Verified date: April 2013
• Source: National Healthcare Group, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism Spectrum Disorders
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Dietary Supplement:
• Omega-3 fatty acids

Locations

Country	Name	City	State
Singapore	Institute of Mental Health	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National Healthcare Group, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment of plasma fatty acid composition, measurements of DHA and EPA (components of omega-3), and total phospholipid count		12 weeks	Yes
Other	Assessment of dietary intake and nutritional intake of the child		12 weeks	Yes
Primary	Change from baseline in parent rated Social Responsiveness Scale (SRS) scores during treatment		12 weeks	No
Secondary	Change from baseline in parent rated Child Behavior Checklist (CBCL) scores during treatment		12 weeks	No
Secondary	Change from baseline in teacher rated Teacher Report (TRF) scores during treatment		12 weeks	No
Secondary	Change from baseline in teacher rated Social Responsiveness Scale (SRS) scores during treatment		12 weeks	No
Secondary	Change from baseline in clinician rated Clinical Global Impression (Severity and Improvements) scores during treatment		12 weeks	No
Secondary	Change from baseline in clinician rated Global Assessment of Functioning (GAF) scores during treatment		12 weeks	No
Secondary	Children's Yale-Brown Obsessive Compulsive Scale modified for Pervasive Developmental Disorders (CYBOCS-PDD)		12 weeks	No