Omega-3 Fatty Acids For Treatment Of Young Children With Autism (OMG)
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 2

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).
    

Detailed description: 
      Currently risperidone is the only medication approved the by Food and Drug Administration
      (FDA) for this disorder, and specifically for irritability associated with autism, although
      not all patients with autism respond to risperidone. No pharmacologic treatments have been
      approved for use in preschool children, although it is clear that early intervention is
      associated with improved outcomes. Behavioral and educational therapies play a significant
      role in the management of autistic symptoms. The history of alternative treatments in autism
      is notable for the exaggerated benefit of a variety of supplements, such as high dose
      vitamins (e.g. B6, magnesium), and secretin. The current widespread use of
      alternative/nutritional supplements to patients with autism without scientifically
      demonstrated efficacy, underscores the necessity for scientifically sound studies to be
      conducted. Complementary and alternative medical therapies (CAM) are commonly employed by
      families of autistic children. Recent surveys have estimated the prevalence of such use to be
      between 30% and 95% (1,2,3). Omega-3 fatty acids were reported to be used in 28.7% of
      patients (1). However, only two small case series and a very small randomized study have been
      reported in this population to date. The investigators propose to conduct a randomized
      controlled trial of omega-3 fatty acids in preschoolers with ASD.
    

Intervention name(s): Omega-3 Fatty Acids; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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.
Other intervention name(s): Nutra Sea HP; Placebo Comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism Spectrum Disorder; Clinical Trial; Omega-3 Fatty Acids; Toddlers