A randomized controlled trial of fish-oil supplementation for children with autism spectrum disorder.
Princess Margaret Hospital
50 participants
Apr 1, 2013
Interventional
Conditions
Summary
Background: Autism Spectrum Disorder (ASD) is the broad term for neurodevelopmental disorders resulting in impairments in social interaction and communication, and a restricted range of activities and interests. Many countries, including Australia, have reported a dramatic increase in the number of diagnoses over the past three decades, and recent estimates put the prevalence of ASD at 1 in every 110 individuals (~1%). The use of specific supplements, nutrients and dietary plans have become widespread, including the use of supplements such as fish oil (currently up to 40%). However, use of these supplements is typically based on parental report and supported by little actual evidence, and therefore fish oil represents an additional invalidated cost to families already spending a considerable sum for their child’s therapy. Aim: The aim of this study is to find out more about the effect of fish oil for children with ASD, by examining the effects on behaviour, cognition and language. Significance: While there have been a small number of studies investigating the effects of fish oil for children with ASD, these studies had a small number of participants, a large age range of participants, a lower dosage and a less varied range of assessments. Approach: We will recruit children with ASD between the ages of 2 to 6 years to receive either 2ml of fish oil liquid daily consisting of a total of 1.08 grams of omega-3 long-chain polyunsaturated fatty acids per day or 2ml of control liquid per day, containing 1 gram of sunflower oil per day. All group supplements will be provided daily for six months, and will consist of a 2ml flavoured liquid, identical in taste and colour. Before and after supplementation children with be assessed using a number of tests assessing behaviour, neurocognition and language, to see if supplementation improved any of these skills.
Eligibility
Inclusion Criteria1
- Children with a DSM-IV diagnosis of ASD (including Autistic Disorder, Pervasive-Developmental Disorder Not Otherwise Specified (PDD-NOS) and Asperger’s Syndrome)
Exclusion Criteria8
- A fish allergy
- Are taking medication for other medical conditions (including diabetes, blood pressure)
- Are currently taking psychotropic medication for the treatment of aggression, tantrums or self-injurious behaviour
- Have diabetes
- Have a bleeding disorder
- Have a seizure disorder
- Have other serious medical conditions
- Current or prior ( < 3 months prior to the intervention) use of omega-3 fatty acids.
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Interventions
Liquid fish oil (2ml daily, 355mg docosahexaenoic acid, 725mg eicosapentaenoic acid) To be taken daily for 6 months. Liquid to be given in the morning before food via 2ml oral syringe. Compliance will be measured through a count of returned unused doses and a parental daily diary. Participants will be weighed (in kg’s) at the initial appointment, and a mg/kg daily dosage will be calculated and used in the data analysis.
Locations(1)
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ACTRN12613000334707