Omega-3 Fatty Acids in Autism Spectrum Disorders

April 30, 2013 updated by: Dr. Sung Min, National Healthcare Group, Singapore

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 168937
        • Institute of Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Omega-3 Fatty Acids
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in parent rated Child Behavior Checklist (CBCL) scores during treatment
Time Frame: 12 weeks
12 weeks
Change from baseline in teacher rated Teacher Report (TRF) scores during treatment
Time Frame: 12 weeks
12 weeks
Change from baseline in teacher rated Social Responsiveness Scale (SRS) scores during treatment
Time Frame: 12 weeks
12 weeks
Change from baseline in clinician rated Clinical Global Impression (Severity and Improvements) scores during treatment
Time Frame: 12 weeks
12 weeks
Change from baseline in clinician rated Global Assessment of Functioning (GAF) scores during treatment
Time Frame: 12 weeks
12 weeks
Children's Yale-Brown Obsessive Compulsive Scale modified for Pervasive Developmental Disorders (CYBOCS-PDD)
Time Frame: 12 weeks
12 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Assessment of plasma fatty acid composition, measurements of DHA and EPA (components of omega-3), and total phospholipid count
Time Frame: 12 weeks
12 weeks
Assessment of dietary intake and nutritional intake of the child
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Healthcare Group, Singapore

Investigators

  • Principal Investigator: Min Sung, MBBS, MMed, National Healthcare Group, Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

September 21, 2012

First Submitted That Met QC Criteria

September 25, 2012

First Posted (Estimate)

September 27, 2012

Study Record Updates

Last Update Posted (Estimate)

May 1, 2013

Last Update Submitted That Met QC Criteria

April 30, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSRB: 2011/00028

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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