Omega-3 Fatty Acids For Treatment Of Young Children With Autism (OMG)
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Intervention: Omega-3 Fatty Acids; Placebo
Intervention description: 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.; 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 2 Years
Maximum age: 5 Years
Healthy volunteers: No
Keywords: Autism Spectrum Disorder; Clinical Trial; Omega-3 Fatty Acids; Toddlers

Summary:

      This is a pilot, randomized, placebo-controlled trial of omega-3 fatty acids in autism.
      Autism, originally described by Kanner in 1943, is among the most severe of
      neurodevelopmental disorders. It is a Pervasive Developmental Disorder (PDD) affecting social
      and communicative functions and is also characterized by repetitive behaviors/restricted
      interests. It is also frequently accompanied by significant aggression, self-injury,
      irritability and hyperactivity, making care for these individuals an even greater challenge
      for families or institutional settings. Autism severely impacts the affected individual and
      family members, causing life-long functional impairment. In this protocol the investigators
      will use the terms "autism" and "autism spectrum disorder (ASD)" interchangeably to refer to
      Autistic disorder, Asperger Syndrome and PDD-Not Otherwise Specified (NOS).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female outpatients 2-5 years of age.

          2. 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)

          3. 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.

          4. Have normal physical examination and laboratory test results at Screening. If
             abnormal, the finding(s) must be deemed clinically insignificant by the Investigator.

          5. The parents must be able to speak and understand English sufficiently to allow for the
             completion of all study assessments.

        Exclusion Criteria:

          1. Patients born prior to 35 weeks gestational age.

          2. 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

          3. 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.

          4. 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.

          5. Patients taking psychoactive medication(s) (e.g.,stimulants, antidepressants,
             antipsychotics, antiepileptics, anxiolytics, clonidine).

          6. Patients that have been off pharmacotherapy for less than 6 weeks.

          7. Patients who are participating in another clinical trial

          8. Patients on anticoagulants

          9. Patients who know that they will initiate or change nonpharmacologic interventions
             during the course of the study.

         10. Patients unable to tolerate venipuncture procedures for blood sampling.

         11. Patients taking Omega-3 supplements who have not discontinued treatment for six weeks
             prior to entering into the study.

         12. Patients who have allergies to any of the ingredients in omega-3 (study product) or
             the placebo.