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CompletedNCT01695200Updated May 1, 2013

Omega-3 Fatty Acids in Autism Spectrum Disorders

A Phase 4 interventional study of Omega-3 fatty acids in Autism Spectrum Disorders, sponsored by National Healthcare Group, Singapore. Completed at 1 site in Singapore. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2013-05-01.

Sponsored by National Healthcare Group, Singapore · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
5 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Autism Spectrum Disorders
03

In context

Autistic Disorder

1,344 studies on the registry are indexed under Autistic Disorder; 333 are open to participants now.

This study's planned enrollment of 60 is above the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.

Browse Autistic Disorder studies →

Lead sponsor

National Healthcare Group, Singapore is the lead sponsor of 14 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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

Interventions

  • Dietary supplementOmega-3 fatty acids
06

What researchers measure

Primary outcomes

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

    Time frame: 12 weeks

Secondary outcomes

  1. Change from baseline in parent rated Child Behavior Checklist (CBCL) scores during treatment

    Time frame: 12 weeks

  2. Change from baseline in teacher rated Teacher Report (TRF) scores during treatment

    Time frame: 12 weeks

  3. Change from baseline in teacher rated Social Responsiveness Scale (SRS) scores during treatment

    Time frame: 12 weeks

  4. Change from baseline in clinician rated Clinical Global Impression (Severity and Improvements) scores during treatment

    Time frame: 12 weeks

  5. Change from baseline in clinician rated Global Assessment of Functioning (GAF) scores during treatment

    Time frame: 12 weeks

  6. Children's Yale-Brown Obsessive Compulsive Scale modified for Pervasive Developmental Disorders (CYBOCS-PDD)

    Time frame: 12 weeks

Other outcomes

  1. Assessment of plasma fatty acid composition, measurements of DHA and EPA (components of omega-3), and total phospholipid count

    Time frame: 12 weeks

  2. Assessment of dietary intake and nutritional intake of the child

    Time frame: 12 weeks

07

Study locations

1 site
  • Institute of Mental Health
    Singapore, 168937, Singapore
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01695200
Lead sponsor
National Healthcare Group, Singapore
Responsible party
Dr. Sung Min (Senior Consultant, National Healthcare Group, Singapore) — Principal investigator
First posted
Sep 27, 2012
Start date
Sep 2011
Primary completion
Jan 2013
Completion
Jan 2013
Last update
May 1, 2013

Study contacts

Min Sung, MBBS, MMed
principal investigator · National Healthcare Group, Singapore

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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