Completed
The Role of Omega-3 Fatty Acids in the Management of Singaporean Children With Autism Spectrum Disorders
What is being tested
Omega-3 fatty acids
Dietary Supplement
Who is being recruted
Mental Disorders+1
+ Child Development Disorders, Pervasive
+ Neurodevelopmental Disorders
From 5 to 18 Years
+11 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 4
Interventional
Study Start: September 2011
Summary
Principal SponsorNational Healthcare Group, Singapore
Last updated: May 1, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2011
Actual date on which the first participant was enrolled.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.
Principal SponsorNational Healthcare Group, Singapore
Last updated: May 1, 2013
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 5 to 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Mental DisordersChild Development Disorders, PervasiveNeurodevelopmental DisordersAutism Spectrum Disorder
Criteria
4 inclusion criteria required to participate
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)
Those not on current standard-of-care treatments for ASD
Written parental consent for participation
7 exclusion criteria prevent from participating
Below 5 and above 18 years old
No formal diagnosis of Autism, Asperger Syndrome or PDD-NOS
Those on current standard-of-care treatment for ASD
Those on other types of medication or supplements or with change in dose
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Experimental15ml omega-3 liquid form, twice a day for 12 weeks (Total daily dosage:840mg DHA and 192mg EPA)
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center