Omega-3 Fatty Acids for Autism Treatment
Condition: Autism
MeSH terms: Autistic Disorder
Intervention: Omega-3 Fatty Acids; Omega-3 Fatty Acids
Intervention description: 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; Omega-3 Fatty Acids in orange pudding form
1 packet two times per day
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 27.0
Sex: All
Minimum age: 3 Years
Maximum age: 8 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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