Efficacy Study of Vayarin in Children With Autism and Comorbid Attention Deficit Hyperactivity Disorder (ADHD)
|ClinicalTrials.gov Identifier: NCT03115671|
Recruitment Status : Completed
First Posted : April 14, 2017
Last Update Posted : August 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder Attention Deficit Hyperactivity Disorder||Dietary Supplement: Vayarin||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Clinicians conducting the study assessments and teachers who will be providing feedback will be blinded to the study arm.|
|Official Title:||An Open-label Pilot Study on the Efficacy of Phosphatidylserine-Omega 3 (Vayarin) in Pediatric Patients Diagnosed With Autism and Comorbid Attention Deficit Hyperactivity Disorder (ADHD)|
|Actual Study Start Date :||November 30, 2016|
|Actual Primary Completion Date :||December 31, 2018|
|Actual Study Completion Date :||December 31, 2018|
Each child participant in the Intervention group will be taking 4 capsules of Vayarin per day for 3 months. Each capsule contains 167mg Lipirinen, providing 75mg Phosphatidylserine (PS), 21.5mg EPA and 8.5mg DHA. This gives a daily dosage of 300mg PS and 120mg EPA/DHA. They may continue their treatment as usual provided there is no change in medication and intervention during the trial.
Dietary Supplement: Vayarin
Other Name: Phosphatidylserine-omega-3 (Lipirinen)
No Intervention: Control
Participants in the Control group will not be given Vayarin. They may continue their treatment as usual provided there is no change in medication and intervention during the trial.
- Conners 3rd Edition - Parent [ Time Frame: 12 weeks, assessed at baseline and week 12 ]Changes from baseline to Week 12 on Conners 3rd Edition - Parent
- Social Responsiveness Scale (SRS) [ Time Frame: 12 weeks, assessed at baseline and week 12 ]Changes from baseline to Week 12 on Social Responsiveness Scale (SRS)
- Aberrant Behaviour Checklist (ABC) [ Time Frame: 12 weeks, assessed at baseline and week 12 ]Change from baseline to Week 12 on the Aberrant Behaviour Checklist (ABC), specifically on irritability subscale
- Physical examination and safety evaluation (PAERS) [ Time Frame: 12 weeks, assessed at baseline, week 6 and week 12 ]Assessments of related side effects and adverse events of the supplements based on physical examination and safety evaluation (as measured by PAERS) at baseline, Week 6 and 12
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03115671
|Child Guidance Clinic|
|Singapore, Singapore, 168937|
|Principal Investigator:||Min Sung, Dr||Institute of Mental Health, Singapore|