Autism Spectrum DisordersPhase 4NCT01695200
Omega-3 Fatty Acids in Autism Spectrum Disorders
A Phase 4 study testing Omega-3 fatty acids in people with Autism Spectrum Disorders, run by National Healthcare Group, Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Autism Spectrum Disorders
- What is being tested?
- Omega-3 fatty acids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSingapore
- Study dates
- Sep 2011to Jan 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Omega-3 Fatty Acids in the Management of Singaporean Children With 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.
- Conditions
- Autism Spectrum Disorders
- Being tested
- Omega-3 fatty acids
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 fatty acidsDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 Fatty Acids | Experimental | 15ml omega-3 liquid form, twice a day for 12 weeks (Total daily dosage:840mg DHA and 192mg EPA) Receives: Dietary Supplement: Omega-3 fatty acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in parent rated Social Responsiveness Scale (SRS) scores during treatment
Measured: 12 weeks
Secondary outcomes (6)
Change from baseline in parent rated Child Behavior Checklist (CBCL) scores during treatment
Measured: 12 weeks
Change from baseline in teacher rated Teacher Report (TRF) scores during treatment
Measured: 12 weeks
Change from baseline in teacher rated Social Responsiveness Scale (SRS) scores during treatment
Measured: 12 weeks
Change from baseline in clinician rated Clinical Global Impression (Severity and Improvements) scores during treatment
Measured: 12 weeks
Change from baseline in clinician rated Global Assessment of Functioning (GAF) scores during treatment
Measured: 12 weeks
Children's Yale-Brown Obsessive Compulsive Scale modified for Pervasive Developmental Disorders (CYBOCS-PDD)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startSep 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Healthcare Group, Singapore
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Sung Min, National Healthcare Group, Singapore
- Investigators
- Min Sung, MBBS, MMed, Principal investigator, National Healthcare Group, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695200
- Sponsor's protocol ID
- DSRB: 2011/00028
- Status last verified
- Apr 2013
- First submitted
- 21 Sep 2012
- Last updated
- 1 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Omega-3 Fatty Acids in the Management of Singaporean Children With Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT01695200
- Acronym / sponsor ID
- DSRB: 2011/00028
- Conditions
- Autism Spectrum Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Healthcare Group, SingaporeOther government
- Study start
- Sep 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 27 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omega-3 Fatty Acids | Experimental | Dietary Supplement: Omega-3 fatty acids15ml omega-3 liquid form, twice a day for 12 weeks (Total daily dosage:840mg DHA and 192mg EPA) |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 fatty acids | Dietary supplement | Omega-3 Fatty Acids |
Primary outcome
Change from baseline in parent rated Social Responsiveness Scale (SRS) scores during treatment
Time frame: 12 weeks
6 secondary outcomes
Change from baseline in parent rated Child Behavior Checklist (CBCL) scores during treatment
Time frame: 12 weeks
Change from baseline in teacher rated Teacher Report (TRF) scores during treatment
Time frame: 12 weeks
Change from baseline in teacher rated Social Responsiveness Scale (SRS) scores during treatment
Time frame: 12 weeks
Change from baseline in clinician rated Clinical Global Impression (Severity and Improvements) scores during treatment
Time frame: 12 weeks
Change from baseline in clinician rated Global Assessment of Functioning (GAF) scores during treatment
Time frame: 12 weeks
Children's Yale-Brown Obsessive Compulsive Scale modified for Pervasive Developmental Disorders (CYBOCS-PDD)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Sung, MBBS, MMed principal investigator
National Healthcare Group, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omega-3 fatty acids in people with Autism Spectrum Disorders, run by National Healthcare Group, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in parent rated Social Responsiveness Scale (SRS) scores during treatment (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2013.