Omega-3 Fatty Acids in Autism Spectrum Disorders

NCT ID: NCT01695200

Last Updated: 2013-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Autism Spectrum Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Omega-3 Fatty Acids

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

Group Type EXPERIMENTAL

Omega-3 fatty acids

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Omega-3 fatty acids

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Healthcare Group, Singapore

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Sung Min

Senior Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Min Sung, MBBS, MMed

Role: PRINCIPAL_INVESTIGATOR

National Healthcare Group, Singapore

Locations

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Institute of Mental Health

Singapore, , Singapore

Site Status

Countries

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Singapore

Other Identifiers

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DSRB: 2011/00028

Identifier Type: -

Identifier Source: org_study_id

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