- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01248728
Omega-3 Fatty Acids For Treatment Of Young Children With Autism (OMG)
A Randomized, Placebo-Controlled Trial of Omega-3 Fatty Acids in the Treatment of Young Children With Autism
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Ontario
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Toronto, Ontario, Canada, M4G 1R8
- Holland Bloorview Kids Rehabilitation Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female outpatients 2-5 years of age.
- Meet Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV) criteria. DSM-IV criteria for an autism spectrum disorder, (Autistic disorder, Asperger syndrome or PDD-NOS) will be established by a clinician with expertise with individuals with ASD based on parent interview, Autism Diagnostic Observation Schedule (ADO) and Autism Diagnostic Interview (ADI-R)
- If already receiving stable non pharmacologic educational, behavioral, dietary and or/ natural health product interventions during the preceding 3 months prior to Screening, will not electively initiate new or modify ongoing interventions for the duration of the study unless the child's condition is worsening or their turn comes up on the treatment waiting list.
- Have normal physical examination and laboratory test results at Screening. If abnormal, the finding(s) must be deemed clinically insignificant by the Investigator.
- The parents must be able to speak and understand English sufficiently to allow for the completion of all study assessments.
Exclusion Criteria:
- Patients born prior to 35 weeks gestational age.
- Patients with any primary psychiatric diagnosis other than autism at Screening. We are aware the most primary psychiatric disorders are unlikely to be diagnosed in this age group
- Patients with a medical history of neurological disease, including, but not limited to, epilepsy/seizure disorder (except simple febrile seizures), movement disorder, tuberous sclerosis, fragile X, and any other known genetic syndromes, or known abnormal MRI/structural lesion of the brain.
- Patients with a medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. Patients with evidence or history of malignancy or any significant hematological, endocrine, cardiovascular (including any rhythm disorder), respiratory, renal, hepatic, or gastrointestinal disease, or coagulation deficits.
- Patients taking psychoactive medication(s) (e.g.,stimulants, antidepressants, antipsychotics, antiepileptics, anxiolytics, clonidine).
- Patients that have been off pharmacotherapy for less than 6 weeks.
- Patients who are participating in another clinical trial
- Patients on anticoagulants
- Patients who know that they will initiate or change nonpharmacologic interventions during the course of the study.
- Patients unable to tolerate venipuncture procedures for blood sampling.
- Patients taking Omega-3 supplements who have not discontinued treatment for six weeks prior to entering into the study.
- Patients who have allergies to any of the ingredients in omega-3 (study product) or the placebo.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Omega-3 Fatty Acids
Children will be administered 3.75ml of the liquid formulation of Nutra Sea high-EPA (HP) (containing 1.5 gr of EPA+DHA).
The starting dose will be 1.875ml (0.75 gr of EPA+DHA) and the dose will be doubled on week 2.
|
Children will be administered 3.75ml of the liquid formulation of Nutra Sea HP (containing 1.5 gr of EPA+DHA).
The starting dose will be 1.875ml (0.75 gr of EPA+DHA) and the dose will be doubled on week 2. The parents may choose to give this as a single dose or split it to two doses if stomach upset occurs.
This formulation is double distilled and has very little fishy taste, which will make it more palatable for children and will make creating a matching placebo a simpler process.
Other Names:
|
Placebo Comparator: Placebo
Children will be administered 3.75ml of the liquid formulation of Placebo.
The starting dose will be 1.875ml and the dose will be doubled on week 2.
|
Children will be administered 3.75ml of the liquid formulation of Placebo.
The starting dose will be 1.875ml and the dose will be doubled on week 2. The parents may choose to give this as a single dose or split it to two doses if stomach upset occurs.
This formulation is double distilled and has very little fishy taste, which will make it more palatable for children and will make creating a matching placebo a simpler process.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in the Pervasive Developmental Disorder-Behavioral Inventory (PDDBI) - Autism Composite Score
Time Frame: Baseline and 24 Weeks
|
The PDDBI measures autism symptomology. The autism composite score was used as the primary outcome measure for autism symptom severity. PDDBI Autism Composite Scale Range: Minimum Range = 10 (lower autism symptom severity) Maximum Range = 100 (higher autism symptom severity) The Autism Composite is calculated from the sum of T-scores of the Sensory/Perceptual Approach Behaviours, Ritualisms/Resistance to Change, Social Pragmatic Problems, and Semantic/Pragmatic Problems domains subtracted by the sum of T-scores of the Social Approach Behaviours, and Expressive Language domain then converted into the Autism Composite as a T-score. Mean change between baseline and week 24 is reported. A negative change indicates improvement |
Baseline and 24 Weeks
|
Change From Baseline in the Behaviour Assessment System for Children (BASC-2) - Externalizing Problems Composite
Time Frame: Baseline and 24 Weeks
|
The BASC-2 externalizing problems composite measures hyperactivity and aggressive behaviours. Primary Outcome domain: Externalizing Problems composite Externalizing Problems Composite T-Score Range: Minimum Range: 10 (lower externalizing problems) Maximum Range: 120 (higher externalizing problems) The Externalizing Problems composite is computed from the sum of t-scores from the hyperactivity and aggression subscales then converted into the externalizing problems composite t-score. Mean change between baseline and week 24 is reported. A negative change indicates improvement. |
Baseline and 24 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Classified as Responders by the Clinical Global Impression - Improvement (CGI-I)
Time Frame: 24 weeks
|
The CGI-I is a seven-point scale that provides a clinician rating of global improvement and as such is already inherently a measure of change. It requires the clinician to assess the degree to which the participant's illness has improved or worsened relative to a baseline state before the intervention. Change is rated as: 0- Not assessed
Participants are classified as responders if their CGI-I score was 1 or 2 and non-responders for CGI-I scores of 3 to 7. |
24 weeks
|
Change From Baseline in the Vineland Adaptive Behavioral Scales (VABS) - Adaptive Functioning Composite
Time Frame: Baseline and 24 Weeks
|
The VABS is a measure of adaptive behavior in daily settings. Secondary measure domain: The adaptive functioning composite describes an individuals overall functioning Adaptive Behaviour Composite Standard Score Range: Minimum range: 20 (low adaptive functioning) Maximum range: 160 (high adaptive functioning) The adaptive behaviour composite standard score is computed from the sum of standard scores from the communication, daily living skills, socialization and motor skills domains and converted into the adaptive behavior composite standard score. Change in the adaptive behaviour composite standard score from baseline to week 24 is reported. Positive change indicates improvement. |
Baseline and 24 Weeks
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Change From Baseline in the Preschool Language Scale (PLS-4) - Total Language
Time Frame: Baseline and 24 Weeks
|
The PLS-4 is a language measure that provides a global assessment of a child's language functioning abilities, receptive and expressive language. Secondary outcome measure domain: Total language standard score Total Language Standard Score Range: Minimum range: 50 (lower language abilities) Maximum range: 150 (higher language abilities) The total language standard score is computed from a sum of the auditory comprehension and expressive communication standard scores, then converted into the total language standard score. Change of total language standard scores from baseline to week 24 is reported. Positive change indicates improvement |
Baseline and 24 Weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Evdokia Anagnostou, M.D., Holland Bloorview Kids Rehabilitation Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-018
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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