Back to resultsOmega-3 Fatty Acids in Autism Spectrum Disorders
Primary Purpose
Autism Spectrum Disorders
Status
Completed
Phase
Phase 4
Locations
Singapore
Study Type
Interventional
Intervention
Omega-3 fatty acids
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorders
Eligibility Criteria
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
Sites / Locations
- Institute of Mental Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Omega-3 Fatty Acids
Arm Description
15ml omega-3 liquid form, twice a day for 12 weeks (Total daily dosage:840mg DHA and 192mg EPA)
Outcomes
Primary Outcome Measures
Change from baseline in parent rated Social Responsiveness Scale (SRS) scores during treatment
Secondary Outcome Measures
Change from baseline in parent rated Child Behavior Checklist (CBCL) scores during treatment
Change from baseline in teacher rated Teacher Report (TRF) scores during treatment
Change from baseline in teacher rated Social Responsiveness Scale (SRS) scores during treatment
Change from baseline in clinician rated Clinical Global Impression (Severity and Improvements) scores during treatment
Change from baseline in clinician rated Global Assessment of Functioning (GAF) scores during treatment
Children's Yale-Brown Obsessive Compulsive Scale modified for Pervasive Developmental Disorders (CYBOCS-PDD)
Full Information
NCT ID
NCT01695200
First Posted
September 21, 2012
Last Updated
April 30, 2013
Sponsor
National Healthcare Group, Singapore
1. Study Identification
Unique Protocol Identification Number
NCT01695200
Brief Title
Omega-3 Fatty Acids in Autism Spectrum Disorders
Official Title
The Role of Omega-3 Fatty Acids in the Management of Singaporean Children With Autism Spectrum Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Healthcare Group, Singapore
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Omega-3 Fatty Acids
Arm Type
Experimental
Arm Description
15ml omega-3 liquid form, twice a day for 12 weeks (Total daily dosage:840mg DHA and 192mg EPA)
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 fatty acids
Primary Outcome Measure Information:
Title
Change from baseline in parent rated Social Responsiveness Scale (SRS) scores during treatment
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in parent rated Child Behavior Checklist (CBCL) scores during treatment
Time Frame
12 weeks
Title
Change from baseline in teacher rated Teacher Report (TRF) scores during treatment
Time Frame
12 weeks
Title
Change from baseline in teacher rated Social Responsiveness Scale (SRS) scores during treatment
Time Frame
12 weeks
Title
Change from baseline in clinician rated Clinical Global Impression (Severity and Improvements) scores during treatment
Time Frame
12 weeks
Title
Change from baseline in clinician rated Global Assessment of Functioning (GAF) scores during treatment
Time Frame
12 weeks
Title
Children's Yale-Brown Obsessive Compulsive Scale modified for Pervasive Developmental Disorders (CYBOCS-PDD)
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Assessment of plasma fatty acid composition, measurements of DHA and EPA (components of omega-3), and total phospholipid count
Time Frame
12 weeks
Title
Assessment of dietary intake and nutritional intake of the child
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Sung, MBBS, MMed
Organizational Affiliation
National Healthcare Group, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Mental Health
City
Singapore
ZIP/Postal Code
168937
Country
Singapore
12. IPD Sharing Statement
Learn more about this trial
Omega-3 Fatty Acids in Autism Spectrum Disorders
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