ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Autism Spectrum Disorders

Condition category

Condition code

Mental Health

Autistic spectrum disorders

Alternative and Complementary Medicine

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]

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]

Total score, and sub-scale scores on the Aberrant Behaviour Checklist (ABC).

Timepoint [1]

Following six months of fish oil or placebo supplementation.

Secondary outcome [1]

Mullen's Scale of Early Learning composite score and sub-scores

Timepoint [1]

Following six months of fish oil or placebo supplementation.

Secondary outcome [2]

Repetitive Behaviour Scale - Revised sub-scores

Timepoint [2]

Following six months of fish oil or placebo supplementation.

Secondary outcome [3]

Clinical Evaluation of Language Fundamentals Pre-School composite and sub-scores.

Timepoint [3]

Following six months of fish oil or placebo supplementation.

Secondary outcome [4]

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]

Following six months of fish oil or placebo supplementation.

Secondary outcome [5]

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]

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]

University

Name [1]

University of Western Australia

Address [1]

35 Stirling Hwy Crawley, Western Australia 6009.

Country [1]

Australia

Primary sponsor type

Hospital

Name

Princess Margaret Hospital

Address

Roberts Rd Subiaco, Western Australia, 6008

Country

Australia

Secondary sponsor category [1]

University

Name [1]

Telethon Institute for Child Health Research, University of Western Australia.

Address [1]

100 Roberts Rd Subiaco, Western Australia 6008

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Princess Margaret HospitL Ethics Committee

Ethics committee address [1]

GPO Box D184 Perth WA 6840

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

08/01/2013

Ethics approval number [1]

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

Dr Suzanne Meldrum

Address

School of Paediatrics & Child Health, University of Western Australia. M561, 35 Stirling Hwy Crawley, Western Australia 6009.

Country

Australia

Phone

+61 8 9340 8340

Fax

Email

[email protected]

Contact person for public queries

Name

Suzanne Meldrum

Address

School of Paediatrics & Child Health, University of Western Australia. M561, 35 Stirling Hwy Crawley, Western Australia 6009.

Country

Australia

Phone

+61 8 9340 8340

Fax

Email

[email protected]

Contact person for scientific queries

Name

Suzanne Meldrum

Address

School of Paediatrics & Child Health, University of Western Australia. M561, 35 Stirling Hwy Crawley, Western Australia 6009.

Country

Australia

Phone

+61 8 9340 8340

Fax

Email

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.