Omega-3 Fatty Acids for Autism Treatment

Study Overview
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Brief Summary
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Omega-3 fatty acids are among the most commonly used CAM (Complementary Alternative Medical) therapies, and have been reported to be currently used by 28.7% of children with autism. Two published case series noted that families reported large improvements in the core feature of autism when children were given omega-3 fatty acids. Low levels of omega-3 fatty acids have been noted in children with autism, which suggests normalizing the omega-3 fatty acid levels could produce improvements in the symptoms seen in many children with autism. This study is a 12-week randomized, double blind, placebo-controlled clinical trial for 24 male and female children aged 3 to 8 years with autism. Patients who are currently using omega-3 would need to discontinue omega-3 fatty acids for 8 weeks before they are able to participate in the study. All study participants who meet all inclusion and no exclusion criteria at the initial screening visit and sign the consent form will then complete baseline assessments of the outcome measures (validated instruments of hyperactivity, communication, social interaction, and behavior) and be randomly assigned to 12 weeks of omega-3 fatty acids at a dose of 1 gm per day or an identical placebo. The child's behavior will be measured and evaluated at the MIND Institute at the beginning of the study and at study closing. All study families will come in for a follow-up visit at weeks 4 and 8 to assess medication compliance and side effects to study medication. After 12 weeks of treatment, all outcome measures including laboratory tests and side effect profiles will be repeated. All patients who complete the study will receive a 12-week supply of omega-3. This would also provide patients who were on placebo with active medication. No follow-up visits are needed once the patient finishes the double-blind portion of the study.

Detailed Description
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Clinical measures will be used to assess diagnosis and efficacy. All clinical assessments will take place at the M.I.N.D. Institute. Baseline and termination measures will include the Aberrant Behavior Checklist (ABC), Peabody Picture Vocabulary Test (PPVT-III), Expressive Vocabulary Test (EVT), Social Responsiveness Scale (SRS), Behavior Assessment System for Children (BASC), and Clinical Global Impression Improvement (CGI-I). The, the Wechsler Preschool Primary Scale of Intelligence - Revised (WPPSI-R), the Wechsler Intelligence Scale for Children (WISC) or the Stanford-Binet will be administered to measure IQ.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled 12-week Study to Investigate the Effect of Omega-3 Fatty Acids on Hyperactivity in Childhood Autism

Conditions
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Autism

Intervention / Treatment
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* Dietary Supplement: Omega-3 Fatty Acids
* Dietary Supplement: Omega-3 Fatty Acids


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of autism as defined by DSM-IV TR and scores above the cutoff on the Autism Diagnostic Observation Scale (ADOS) and the Social Communication Questionnaire (SCQ) Age three to eight years Non-verbal IQ of 50 or above Children on a stable medical regimen for the past 2 months and no plans to change medical therapy for the study period Exclusion Criteria: Individuals with allergy or hypersensitivity to fish or nuts Diabetes Bleeding disorder, current use of anticoagulant or anti-platelet therapy, or recent surgery Clinical evidence of seizure disorder Cancer Fragile X or other known genetic cause of autism Perinatal brain injury Evidence for malnutrition seen in abnormal albumin level Other serious medical illness Current use of omega-3 fatty acids

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Omega-3 Fatty Acids<br> | Dietary Supplement: Omega-3 Fatty Acids<br>* Omega-3's are administered in the form of an orange pudding made by Coromega 1 mg of omega-3 fatty acid 2 times per day<br>* Other names: Omega-3, N-3 Fatty Acid;|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Omega-3 Fatty Acids<br>* Omega-3 Fatty Acids in orange pudding form 1 packet two times per day<br>* Other names: Omega-3, N-3 Fatty Acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Group-specific and Comparison of Change in Aberrant Behavior Checklist-Hyperactivity Subscale Score (Active Omega-3 Group Only, Placebo Group Only and Comparison Between Groups) | Hyperactivity subscale of Aberrant Behavior checklist (ABC-H): measure of assessing changes in symptoms of hyperactivity in children with autism (survey that was normed on a developmentally delayed population of children and adults and is usually completed by a parent or caregiver. Items are rated on a 4-point scale from no problem to major problem). ABC-H Subscale Score ranges from 0 (best) to 45 (worst). A negative change signifies improvement. | Baseline and 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Percentage of Serum Omega-3 Fatty Acids | Change in percentage calculated as (100% * ((One Year - Baseline)/Baseline) | Baseline and 1 year | 
| Change in Serum TNFα (Cytokine) Level |  | Baseline and 1 year |