Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000962831
Ethics application status
Approved
Date submitted
6/09/2012
Date registered
6/09/2012
Date last updated
16/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Omega-3s, learning and behaviour in primary school children
Scientific title
Randomised controlled trial investigating effects of omega-3 fatty acids on literacy, attention, behaviour and quality of life in primary school children
Secondary ID [1] 281182 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Literacy 287354 0
Attention 287355 0
Behaviour 287356 0
Quality of Life 287357 0
Condition category
Condition code
Mental Health 287686 287686 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fish oil supplement Equazen ‘eye qTM’, each capsule containing 400 mg fish oil and 100 mg evening primrose oil with active ingredients EPA (93 mg), DHA (29 mg), GLA (10 mg), and vitamin E (1.8 mg). Children are given 6 capsules per school day over 20 weeks, i.e. 2 x 10-week school terms (separated by 2 weeks school holiday) by teaching assistants and these school staff will record compliance daily.
Intervention code [1] 285636 0
Behaviour
Comparator / control treatment
Identical looking placebo capsules containing palm oil with a fraction of fish oil to give a fishy odour and flavour.
Control group
Placebo

Outcomes
Primary outcome [1] 287928 0
Literacy: Word Reading and Spelling, measured on the WRAT (Wide Range Achievement Test)
Timepoint [1] 287928 0
Baseline and 20 weeks (i.e. 20 school weeks with 2-week holiday inbetween)
Primary outcome [2] 287929 0
Conners Behaviour Rating Scales for teachers and parents, abbreviated
Timepoint [2] 287929 0
Baseline and 20 weeks (i.e. 20 school weeks with 2-week holiday inbetween)
Secondary outcome [1] 299067 0
Draw-A-Person - non-verbal assessment of cognitive development
Timepoint [1] 299067 0
Baseline and 20 weeks (i.e. 20 school weeks with 2-week holiday inbetween)
Secondary outcome [2] 299068 0
Conners' Continuous Performance Task II, computerised
Timepoint [2] 299068 0
Baseline and 20 weeks (i.e. 20 school weeks with 2-week holiday inbetween)
Secondary outcome [3] 299069 0
The Peds-QL TM, measuring Pediatric Quality of Life - administered to children, parents and teachers
Timepoint [3] 299069 0
Baseline and 20 weeks (i.e. 20 school weeks with 2-week holiday inbetween)

Eligibility
Key inclusion criteria
All children attending participating primary schools
Minimum age
7 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Taking fish oil supplements

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Children were enrolled via parent consent forms. Supplements were numbered and child's name put on their supplement bottle via numbers generated independently from the randomisation procedure.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Children were allocated to treatment conditions via the process of minimisation based on age, gender and school.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/03/2012
Actual
10/03/2012
Date of last participant enrolment
Anticipated
29/06/2012
Actual
29/06/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
90
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5730 0
5086
Recruitment postcode(s) [2] 5731 0
5075
Recruitment postcode(s) [3] 5732 0
5085
Recruitment postcode(s) [4] 5733 0
5092

Funding & Sponsors
Funding source category [1] 285952 0
Self funded/Unfunded
Name [1] 285952 0
Natalie Parletta
Country [1] 285952 0
Australia
Primary sponsor type
Individual
Name
Natalie Parletta
Address
Sansom Institute for Health Research
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 284780 0
None
Name [1] 284780 0
Address [1] 284780 0
Country [1] 284780 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287987 0
Human Research Ethics Committee, University of South Australia
Ethics committee address [1] 287987 0
University of South Australia
GPO Box 2471
Adelaide SA 5001
Ethics committee country [1] 287987 0
Australia
Date submitted for ethics approval [1] 287987 0
Approval date [1] 287987 0
27/11/2011
Ethics approval number [1] 287987 0
0000026351
Ethics committee name [2] 287988 0
Department for Education and Children's Development
Ethics committee address [2] 287988 0
31 Flinders Street
ADELAIDE SA 5000

Postal address
GPO Box 1152
ADELAIDE SA 5001
Ethics committee country [2] 287988 0
Australia
Date submitted for ethics approval [2] 287988 0
Approval date [2] 287988 0
27/01/2012
Ethics approval number [2] 287988 0

Summary
Brief summary
Omega-3s in fish oil are important for brain function and Australian children are not consuming enough in their diet. The purpose of this study is to give primary school children fish oil capsules or placebo capsules to determine whether the fish oil capsules assist them with their learning and behaviour, specifically literacy, attention, cognitive development, and parent/teacher reports of learning and behaviour as well as quality of life.
Trial website
n/a
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 34679 0
Dr Natalie Parletta
Address 34679 0
University of South Australia
GPO Box 2471
Internal postcode CEA-08
Adelaide SA 5001, Australia
Country 34679 0
Australia
Phone 34679 0
+61883021757
Fax 34679 0
Email 34679 0
[email protected]
Contact person for public queries
Name 17926 0
Dr Dr Natalie Parletta
Address 17926 0
Sansom Institute for Health Research
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country 17926 0
Australia
Phone 17926 0
+61 8 8302 1757
Fax 17926 0
Email 17926 0
[email protected]
Contact person for scientific queries
Name 8854 0
Dr Dr Natalie Parletta
Address 8854 0
Sansom Institute for Health Research
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country 8854 0
Australia
Phone 8854 0
+61 8 8302 1757
Fax 8854 0
Email 8854 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.