Omega-3 Fatty Acids in Autism Spectrum Disorders

National Healthcare Group, Singapore

Status and phase: Completed; Phase 4

Conditions: Autism Spectrum Disorders

Treatments: Dietary Supplement: Omega-3 fatty acids

Study type: Interventional

Funder types: Other

Identifiers

NCT01695200

DSRB: 2011/00028

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Omega-3 Fatty Acids

Experimental group

Description:

15ml omega-3 liquid form, twice a day for 12 weeks (Total daily dosage:840mg DHA and 192mg EPA)

Treatment:

Dietary Supplement: Omega-3 fatty acids