Omega-3 Fatty Acids for Autism Treatment
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      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.
    

Intervention name(s): Omega-3 Fatty Acids; Omega-3 Fatty Acids
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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
Other intervention name(s): Omega-3, N-3 Fatty Acid; Omega-3, N-3 Fatty Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment