Efficacy Study of Vayarin in Children With Autism and Comorbid Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Autism Spectrum Disorder; Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Autistic Disorder; Attention Deficit Disorder with Hyperactivity; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      This research study is carried out to examine the effects of Phosphatidylserine-Omega 3
      supplements (i.e., Vayarin) among children with Autism Spectrum Disorder (ASD) and ADHD.
      Participants will be randomised either to receive the Vayarin treatment (Intervention group)
      or to a Control group.
    

Detailed description: 
      There has been growing interest in the role of supplements such as omega-3 polyunsaturated
      fatty acids (n-3 PUFAs) in ADHD and ASD. Two of the primary n-3 PUFAs are eicosapentaenoic
      acid (EPA) and docosahexaenoic acid (DHA), which are critical to brain development and are
      usually obtained through our diets. Increasing evidence has shown that children with ASD
      and/or ADHD have lower overall blood n-3 PUFAs levels than typically developing children
      (Parletta, Niyonsenga & Duff, 2016). Therefore, many studies have been conducted to examine
      the effectiveness of n-3 PUFAs supplementation among these two populations. While these
      supplements were found to have small but reliable benefit on ADHD symptoms (Hawkey & Nigg,
      2014), there is limited evidence to support the use of n-3 PUFAs in clinical practice for the
      treatment of behavioural symptoms in children with ASD (James, Montgomery & Williams, 2011;
      Roux, 2015). Such inconsistencies give rise to the exploration of other alternatives in
      administering n-3 PUFAs.

      Phosphatidylserine (PS), an acidic phospholipid (PL) molecule, comprises of a glycerol
      backbone esterified to the hydroxyl group of the amino acid serine via a phosphate group and
      to two fatty acids moiety (Manor et al., 2012). It plays a key role in the functioning of
      neuron membranes and may enhance the bioavailability of PUFAs. Administration of PL
      containing omega-3 PUFAs showed greater improvement in visual sustained attention performance
      among school children with ADHD, as compared to placebo and fish oil groups (Vaisman et al.,
      2008). Similarly, another study also suggested the benefits of PS-Omega3 (i.e., Vayarin) in
      reducing ADHD symptoms (Manor et al., 2012). This supplementation is shown to be generally
      safe and well-tolerated (Manor et al., 2013).

      Nevertheless, these studies were conducted among children with ADHD. Given that n-3 PUFAs are
      commonly used by children with comorbid ASD and ADHD, there is a need to examine whether
      similar effects can be observed in this population. The goal of our present study is to
      examine the effect of PS-Omega3 supplement among children with comorbid ASD and ADHD. The
      safety and tolerability will also be assessed in this pilot trial.
    

Intervention name(s): Vayarin
Intervention type(s): Dietary Supplement
Intervention description(s): Vayarin capsule
Other intervention name(s): Phosphatidylserine-omega-3 (Lipirinen)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Phosphatidylserine; Omega-3