A randomized controlled trial of fish-oil supplementation for children with autism spectrum disorder.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000334707

Enrollment

Registered

2013-03-26

Start date

2013-04-01

Completion date

2014-04-01

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

2 Years to 6 Years

Healthy volunteers

Inclusion criteria

Children with a DSM-IV diagnosis of ASD (including Autistic Disorder, Pervasive-Developmental Disorder Not Otherwise Specified (PDD-NOS) and Asperger’s Syndrome)

Exclusion criteria

1. A fish allergy 2. Are taking medication for other medical conditions (including diabetes, blood pressure) 3. Are currently taking psychotropic medication for the treatment of aggression, tantrums or self-injurious behaviour 4. Have diabetes 5. Have a bleeding disorder 6. Have a seizure disorder 7. Have other serious medical conditions 8. Current or prior ( < 3 months prior to the intervention) use of omega-3 fatty acids.

Outcome results