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Trial registered on ANZCTR


Registration number
ACTRN12613000334707
Ethics application status
Approved
Date submitted
25/03/2013
Date registered
26/03/2013
Date last updated
26/03/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized controlled trial of fish-oil supplementation for children with autism spectrum disorder.
Scientific title
A randomized controlled trial of fish-oil supplementation for children with autism spectrum disorder.
Secondary ID [1] 282176 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorders 288686 0
Condition category
Condition code
Mental Health 289038 289038 0 0
Autistic spectrum disorders
Alternative and Complementary Medicine 289042 289042 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 286785 0
Treatment: Other
Comparator / control treatment
Liquid sunflower oil 2ml daily
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.
Control group
Placebo

Outcomes
Primary outcome [1] 289151 0
Total score, and sub-scale scores on the Aberrant Behaviour Checklist (ABC).
Timepoint [1] 289151 0
Following six months of fish oil or placebo supplementation.
Secondary outcome [1] 301935 0
Mullen's Scale of Early Learning composite score and sub-scores


Timepoint [1] 301935 0
Following six months of fish oil or placebo supplementation.
Secondary outcome [2] 301938 0
Repetitive Behaviour Scale - Revised sub-scores
Timepoint [2] 301938 0
Following six months of fish oil or placebo supplementation.
Secondary outcome [3] 301939 0
Clinical Evaluation of Language Fundamentals Pre-School composite and sub-scores.
Timepoint [3] 301939 0
Following six months of fish oil or placebo supplementation.
Secondary outcome [4] 301940 0
N-3 LCPUFA (EPA and DHA) measurements and their relationship to outcome measures. A 10ml blood sample will be taken from children by venipuncture of the cubital-fossa vein for baseline and the two post-supplementation analysis of plasma and erythrocyte phospholipid fatty acid concentrations.
Timepoint [4] 301940 0
Following six months of fish oil or placebo supplementation.
Secondary outcome [5] 301941 0
Frequency and type of any adverse events across the 6 months of supplementation.

Phone calls will be made to participants on a monthly basis to monitor compliance and any adverse events using the UKU side effect rating scale. Side effects noted in the use of fish oil include some gastrointestinal complaints (loose stools, nausea), unpleasant fish reflux/burps, heart burn or indigestion and nose bleeds.
Timepoint [5] 301941 0
Following six months of fish oil or placebo supplementation.

Eligibility
Key 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)
Minimum age
2 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Children who satisfy all eligibility criteria will be randomly assigned to one of two groups. Participants in both groups will receive matched containers, labelled with study number and participant name. Dispensation and delivery of the products will occur by the Princess Margaret Hospital staff, unaware of group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomized using a computer-generated randomization list by the Princess Margaret Hospital Pharmacy. Randomization will be stratified according to age (2-4.4 years, 4.5-6 years), gender (male, female) and ASD diagnosis severity (total of sub scale means > 31.57, total <31.56.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Analysis will be performed on an intention-to-treat basis including all participants with outcomes data available.

For the primary outcome measure, we will compare baseline and post-supplementation assessment outcomes of the treatment and placebo groups using unadjusted linear regression. For the secondary analysis, the treatment groups will also be compared using adjusted linear regression.

As a sensitivity analysis, regression models will also be fitted to the primary and secondary outcomes adjusted for pre-supplementation scores on the outcome measure of interest, age, gender and ABC score at baseline (as used in the randomization) and any other baseline and demographic variables where an imbalance is found.

P values less than 0.05 will be considered statistically significant.

Based on the previous study by Amminger et al. (Biol Psychiatry. 2007;4:551-3), a sample size of 25 participants has 82.5% power to detect a 25% reduction in the mean baseline hyperactivity scale of the ABC (two tailed). Therefore a sample size of 50 will be more than adequate to detect any statistically significant differences between groups.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2013
Actual
Date of last participant enrolment
Anticipated
1/04/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 286945 0
University
Name [1] 286945 0
University of Western Australia
Country [1] 286945 0
Australia
Primary sponsor type
Hospital
Name
Princess Margaret Hospital
Address
Roberts Rd Subiaco, Western Australia, 6008
Country
Australia
Secondary sponsor category [1] 285732 0
University
Name [1] 285732 0
Telethon Institute for Child Health Research, University of Western Australia.
Address [1] 285732 0
100 Roberts Rd Subiaco, Western Australia 6008
Country [1] 285732 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288998 0
Princess Margaret HospitL Ethics Committee
Ethics committee address [1] 288998 0
GPO Box D184 Perth WA 6840
Ethics committee country [1] 288998 0
Australia
Date submitted for ethics approval [1] 288998 0
Approval date [1] 288998 0
08/01/2013
Ethics approval number [1] 288998 0
2053/EP

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38722 0
Dr Suzanne Meldrum
Address 38722 0
School of Paediatrics & Child Health, University of Western Australia. M561, 35 Stirling Hwy Crawley, Western Australia 6009.
Country 38722 0
Australia
Phone 38722 0
+61 8 9340 8340
Fax 38722 0
Email 38722 0
[email protected]
Contact person for public queries
Name 38723 0
Suzanne Meldrum
Address 38723 0
School of Paediatrics & Child Health, University of Western Australia. M561, 35 Stirling Hwy Crawley, Western Australia 6009.
Country 38723 0
Australia
Phone 38723 0
+61 8 9340 8340
Fax 38723 0
Email 38723 0
[email protected]
Contact person for scientific queries
Name 38724 0
Suzanne Meldrum
Address 38724 0
School of Paediatrics & Child Health, University of Western Australia. M561, 35 Stirling Hwy Crawley, Western Australia 6009.
Country 38724 0
Australia
Phone 38724 0
+61 8 9340 8340
Fax 38724 0
Email 38724 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



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