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Completed

NCT Number: NCT01695200

Omega-3 Fatty Acids in 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.

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Key information

Conditions

Autism Spectrum Disorders Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Institute of Mental Health

Singapore, 168937

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega-3 fatty acids

Dietary Supplement

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

Sponsors and collaborators

Lead sponsor

National Healthcare Group, Singapore

Other Gov

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 27, 2012
Registry last updated
May 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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