Omega-3 Fatty Acids in Autism Spectrum Disorders

NCT01695200 | Completed Phase 4

• 1 other identifier: DSRB: 2011/00028
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorders

Outcome Measures

Primary Outcomes (1)

• Change from baseline in parent rated Social Responsiveness Scale (SRS) scores during treatment

  12 weeks

Secondary Outcomes (6)

• 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

Other Outcomes (2)

• 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

Study Arms (1)

Omega-3 Fatty Acids

EXPERIMENTAL

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

Interventions

Omega-3 fatty acids DIETARY_SUPPLEMENT

Omega-3 Fatty Acids

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Healthcare Group, Singapore: lead

Study Sites (1)

Institute of Mental Health

Singapore, 168937, Singapore

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Min Sung, MBBS, MMed

  National Healthcare Group, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: September 21, 2012
• First Posted: September 27, 2012
• Study Start: September 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: May 1, 2013

Record last verified: 2013-04

Locations

SG (1)