Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000017921
Ethics application status
Approved
Date submitted
8/12/2010
Date registered
6/01/2011
Date last updated
13/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Nutrition, learning and behaviour - Effects of omega-3 fatty acids on learning and behaviour of children in Indigenous Northern Territory schools: a randomised controlled trial with one-way crossover
Scientific title
Effects of omega-3 fatty acids on learning and behaviour of children in Indigenous Northern Territory schools: a randomised controlled trial with one-way crossover
Secondary ID [1] 253260 0
N/a
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention, learning and behaviour 258789 0
Condition category
Condition code
Mental Health 258929 258929 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fish oil in small capsules providing a total of EPA 552mg, DHA 168mg, GLA 60mg, Vit E 9.6mg per day on school days throughout 2 x 10-week school terms (Phase 1) then both treatment and placebo groups will take active fish oil for a further 2 x 10 week school terms following a 4-week semester break (Phase 2) in a one-way crossover.
Intervention code [1] 257725 0
Treatment: Other
Intervention code [2] 257769 0
Lifestyle
Comparator / control treatment
Fractionated coconut oil as placebo oil, to be given daily on school days throughout 2 x 10-week school terms (Phase 1)
Control group
Placebo

Outcomes
Primary outcome [1] 259792 0
Literacy: word reading and spelling (assessed individually using the Wide Range Achievement Test (WRAT)
Timepoint [1] 259792 0
Baseline, 20 weeks (with one week term break, then 4 weeks semester break), 40 weeks
Primary outcome [2] 289829 0
Draw-A-Person (DAP) non-verbal test of cognition
Timepoint [2] 289829 0
Baseline, 20 weeks and 40 weeks
Secondary outcome [1] 268580 0
Conners Teacher Behaviour Rating Scales
Timepoint [1] 268580 0
Baseline, 20 weeks (with one week term break, then 4 weeks semester break), 40 weeks
Secondary outcome [2] 268583 0
School grades
Timepoint [2] 268583 0
Baseline, 20 weeks (with one week term break, then 4 weeks semester break), 40 weeks
Secondary outcome [3] 268584 0
School behaviour indices, e.g. suspensions, detentions
Timepoint [3] 268584 0
Baseline, 20 weeks (with one week term break, then 4 weeks semester break), 40 weeks
Secondary outcome [4] 268585 0
Conners Parent Behaviour Rating Scales (optional, for parents who can read and write in English)
Timepoint [4] 268585 0
Baseline, 20 weeks (with one week term break, then 4 weeks semester break), 40 weeks

Eligibility
Key inclusion criteria
All children at participating schools with parental consent
Minimum age
6 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non-consent

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)
Allocation will be concealed using numbered containers; children will be independently randomised to numbers corresponding to treatment or placebo following enrolment in the study based on age, gender and school
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Minimisation (by age, gender and school)
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
Crossover
Other design features
Parallel for 20 weeks (with one week school term break at 10 weeks), then one-way crossover to active treatment for a further 20 weeks (after 4 week semester break)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Retrospective target sample size calculation: 60 per group required to achieve a medium effect size with power of 80 (Cohen) - total 120 + 30% drop out = 160. All children attending the participating schools were invited to take part so there was no upper limit. Data were analysed using linear mixed modelling.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/11/2010
Actual
11/11/2010
Date of last participant enrolment
Anticipated
Actual
17/05/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
409
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3504 0
0851
Recruitment postcode(s) [2] 3505 0
0852

Funding & Sponsors
Funding source category [1] 258182 0
Government body
Name [1] 258182 0
Australian Research Council Linkage Grant LP100100863
Country [1] 258182 0
Australia
Funding source category [2] 258183 0
Commercial sector/Industry
Name [2] 258183 0
Vifor Pharma
Country [2] 258183 0
Switzerland
Primary sponsor type
University
Name
University of South Australia
Address
GPO Box 2471
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 257360 0
None
Name [1] 257360 0
N/a
Address [1] 257360 0
Country [1] 257360 0
Other collaborator category [1] 251726 0
Government body
Name [1] 251726 0
Northern Territory Department of Education and Training
Address [1] 251726 0
GPO Box 4821,
Darwin NT 0801
Country [1] 251726 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260176 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 260176 0
Ethics committee country [1] 260176 0
Australia
Date submitted for ethics approval [1] 260176 0
30/03/2010
Approval date [1] 260176 0
11/11/2010
Ethics approval number [1] 260176 0
P041/10
Ethics committee name [2] 260177 0
Human Research Ethics Committee of the
NT Department of Health & Families and Menzies School of Health Research
Ethics committee address [2] 260177 0
Ethics committee country [2] 260177 0
Australia
Date submitted for ethics approval [2] 260177 0
30/03/2010
Approval date [2] 260177 0
18/10/2010
Ethics approval number [2] 260177 0
HREC10/1362

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32000 0
Dr Natalie (Sinn) Parletta
Address 32000 0
School of Population Health
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country 32000 0
Australia
Phone 32000 0
+61 8 8302 1757
Fax 32000 0
Email 32000 0
[email protected]
Contact person for public queries
Name 15247 0
Dr Natalie (Sinn) Parletta
Address 15247 0
Sansom Institute for Health Research
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country 15247 0
Australia
Phone 15247 0
+61 8 8302 1757
Fax 15247 0
+61 8 8302 2794
Email 15247 0
[email protected]
Contact person for scientific queries
Name 6175 0
Dr Natalie (Sinn) Parletta
Address 6175 0
Sansom Institute for Health Research
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country 6175 0
Australia
Phone 6175 0
+61 8 8302 1757
Fax 6175 0
+61 8 8302 2794
Email 6175 0
[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.