Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000753257
Ethics application status
Approved
Date submitted
17/07/2009
Date registered
28/08/2009
Date last updated
16/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Nutrition, learning and behaviour: An investigation of psychometric assessments and feasibility of omega-3 fatty acid supplementation in indigenous childrem from remote Northern Territory schools
Scientific title
Pilot study investigating psychometric assessments and feasibility of omega-3 fatty acid supplementation in indigenous children from 2-3 remote Northern Territory schools
Secondary ID [1] 287897 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Learning and behaviour in indigenous children from 2-3 remote community schools 237285 0
Condition category
Condition code
Diet and Nutrition 239612 239612 0 0
Other diet and nutrition disorders
Mental Health 239890 239890 0 0
Learning disabilities

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Psychometric assessments conducted at baseline 1 (beginning of school term) and then after 9 weeks (baseline 2 - end of school term) followed by an open label pilot study providing 750mg omega-3 fatty acids per day (5 days per week) in fish oil capsules for 9 weeks during the following school term.
Intervention code [1] 236964 0
Treatment: Other
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 238397 0
Literacy, assessed by the Reading and Spelling subtests from the Wide Range Achievement Test (WRAT)
Timepoint [1] 238397 0
Beginning of school term (baseline 1), week 9 (baseline 2), week 20 (week 9 of following school term after one term's fish oil supplementation)
Primary outcome [2] 238398 0
Teacher ratings of children's attention and behaviour: Conners' Teacher Rating Scales (CTRS) short form
Timepoint [2] 238398 0
Beginning of school term (baseline 1), week 9 (baseline 2), week 20 (week 9 of following school term after one term's fish oil supplementation)
Secondary outcome [1] 244864 0
Abstract reasoning: Ravens Coloured Matrices
Timepoint [1] 244864 0
Beginning of school term (baseline 1), week 9 (baseline 2), week 20 (week 9 of following school term after one term's fish oil supplementation)
Secondary outcome [2] 257314 0
Non-verbal IQ: Wechsler Non-Verbal (WNV)
Timepoint [2] 257314 0
Beginning of school term (baseline 1), week 9 (baseline 2), week 20 (week 9 of following school term after one term's fish oil supplementation)
Secondary outcome [3] 257315 0
Level of development: Draw-A-Person test
Timepoint [3] 257315 0
Beginning of school term (baseline 1), week 9 (baseline 2), week 20 (week 9 of following school term after one term's fish oil supplementation)

Eligibility
Key inclusion criteria
Children of consenting parents from small remote community schools
Minimum age
4 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non-consent from parents or child

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Parents of children from small remote community schools in the Northern Territory will be approached to inform them about the study at their school and seek their consent.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Psychometric assessments will take place at 3 time points - two baseline assessments at the beginning of one school term and week 9. Supplementation will commence at the beginning of the following school term and final assesments 9 weeks later.
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/07/2009
Actual
22/07/2009
Date of last participant enrolment
Anticipated
Actual
28/05/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
47
Recruitment in Australia
Recruitment state(s)
NT

Funding & Sponsors
Funding source category [1] 237349 0
University
Name [1] 237349 0
University of South Australia
Country [1] 237349 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
GPO Box 2471
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 236840 0
Commercial sector/Industry
Name [1] 236840 0
Novasel Australia
Address [1] 236840 0
PO Box 341
Mudgeeraba, QLD, 4213
Country [1] 236840 0
Australia
Other collaborator category [1] 765 0
Government body
Name [1] 765 0
Katherine Group School
Address [1] 765 0
PO Box 1546
Katherine NT 0851
Country [1] 765 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239476 0
University of South Australia
Ethics committee address [1] 239476 0
Ethics committee country [1] 239476 0
Australia
Date submitted for ethics approval [1] 239476 0
Approval date [1] 239476 0
16/07/2009
Ethics approval number [1] 239476 0
P137/09
Ethics committee name [2] 239477 0
Human Research Ethics Committee of the NT Department of Health & Families and Menzies School of Health Research
Ethics committee address [2] 239477 0
Ethics committee country [2] 239477 0
Australia
Date submitted for ethics approval [2] 239477 0
Approval date [2] 239477 0
14/07/2009
Ethics approval number [2] 239477 0
09/44

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

Contacts
Principal investigator
Name 29921 0
Dr Natalie Parletta
Address 29921 0
School of Health Sciences
University of South Australia
GPO Box 2471, CEA-08
Adelaide SA 5001
Country 29921 0
Australia
Phone 29921 0
+61883021757
Fax 29921 0
Email 29921 0
[email protected]
Contact person for public queries
Name 13168 0
Dr Natalie Parletta
Address 13168 0
University of South Australia
GPO Box 2471
Adelaide SA 5000
Country 13168 0
Australia
Phone 13168 0
+61 8 8302 1757
Fax 13168 0
+61 8 8302 2178
Email 13168 0
[email protected]
Contact person for scientific queries
Name 4096 0
Dr Natalie Parletta
Address 4096 0
University of South Australia
GPO Box 2471
Adelaide SA 5000
Country 4096 0
Australia
Phone 4096 0
+61 8 8302 1757
Fax 4096 0
+61 8 8302 2178
Email 4096 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
SourceTitleYear of PublicationDOI
Dimensions AICan health partnerships re-orientate health care toward prevention?2011https://doi.org/10.1111/j.1753-6405.2011.00764.x
Dimensions AIFish oil supplementation, learning and behaviour in Indigenous Australian children from a remote community school: a pilot feasibility study2011https://doi.org/10.1111/j.1753-6405.2011.00765.x
N.B. These documents automatically identified may not have been verified by the study sponsor.