Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000731190
Ethics application status
Approved
Date submitted
10/05/2019
Date registered
16/05/2019
Date last updated
27/02/2020
Date data sharing statement initially provided
16/05/2019
Date results information initially provided
27/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Omega Kid Study: Investigating the effect of omega-3 fats for behaviour in 3-5 year old children.
Scientific title
Omega Kid Study: Investigating the effect of omega-3 supplementation for self-regulation in children aged 3-5 years old.
Secondary ID [1] 297971 0
None
Universal Trial Number (UTN)
U1111-1231-6483
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Self-regulation 312379 0
Executive Function 312380 0
Condition category
Condition code
Mental Health 310938 310938 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Omega-3 supplementation of 1.59g (combined docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA)) per day for 12 weeks administered in an encapsulated omega-3 powder.
The main marker for adherence to the intervention is the change in omega-3 blood levels. A calendar sheet will be used for parents to track their child's consumption of the powder, and this will be returned at the end of the study.
Dietary intake of omega-3 at baseline will be captured using the Polyunsaturated Fatty Acid Food Frequency Questionnaire.
Intervention code [1] 314192 0
Treatment: Other
Comparator / control treatment
Placebo control consisting of powder with encapsulated high oleic acid sunflower oil.
Control group
Placebo

Outcomes
Primary outcome [1] 319753 0
Self-regulation determined by Head, Toes, Knees, Shoulders Task score
Timepoint [1] 319753 0
Baseline and 12 weeks after intervention commencement
Primary outcome [2] 319754 0
Self-regulation determined by the Child Self-Regulation and Behaviour Questionnaire
Timepoint [2] 319754 0
Baseline and 12 weeks after intervention commencement
Secondary outcome [1] 369499 0
Executive Function determined by the Go/No-Go task
Timepoint [1] 369499 0
Baseline and 12 weeks after intervention commencement
Secondary outcome [2] 369500 0
Executive Function determined by the "Mr Ant" Task
Timepoint [2] 369500 0
Baseline and 12 weeks after intervention commencement
Secondary outcome [3] 369501 0
Executive Function determined by the Behaviour Rating Inventory of Executive Functioning - Preschool Version Questionnaire
Timepoint [3] 369501 0
Baseline and 12 weeks after intervention commencement
Secondary outcome [4] 369502 0
Electroencephalographic (EEG) recording and subsequent quantification of EEG power in the delta, theta, alpha, and beta frequency bands from each task (eyes-open resting, eyes-closed resting and executive function tasks) will allow measures of nervous system arousal level (from the eyes-closed resting task).
Timepoint [4] 369502 0
Baseline and 12 weeks after intervention commencement
Secondary outcome [5] 369507 0
Attention Deficit Hyperactivity Disorder (ADHD) symptoms determined by the Conner's Teacher Rating Scale-15
Timepoint [5] 369507 0
Baseline and 12 weeks after intervention commencement
Secondary outcome [6] 369508 0
"HS-Omega-3 Index" levels using finger prick blood samples
Timepoint [6] 369508 0
Baseline and 12 weeks after intervention commencement
Secondary outcome [7] 370372 0
Electroencephalographic (EEG) recording and subsequent quantification of EEG power in the delta, theta, alpha, and beta frequency bands from each task (eyes-open resting, eyes-closed resting and executive function tasks) will allow a measure of nervous system activation (difference in EEG in the eyes-open resting compared to eyes-closed resting tasks).
Timepoint [7] 370372 0
Baseline and 12 weeks after intervention commencement
Secondary outcome [8] 370373 0
Electroencephalographic (EEG) recording and subsequent quantification of EEG power in the delta, theta, alpha, and beta frequency bands from each task (eyes-open resting, eyes-closed resting and executive function tasks) will allow a measure of task related activation by comparing eyes-open EEG with EEG during the "Mr Ant" and the "Go/No-Go" iPad based executive function tasks (giving a measure of change in brain activity associated with doing the executive function tasks).
Timepoint [8] 370373 0
Baseline and 12 weeks after intervention commencement

Eligibility
Key inclusion criteria
Children aged 3 to 5 years old.
Minimum age
3 Years
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals outside the specified age range.
Children with allergies to the supplements.
Children with blood clotting disorders.
Children on blood thinning medication.
Children with an upcoming surgical procedure.
Children with a known developmental delay (but not ADHD).

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computerised sequence generator
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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As this study is a pilot feasibility trial we will aim to recruit up to 140 children. Allowing for an approximate drop out rate of 30% will result in up to 100 children completing the trial and 50 per group. We anticipate that this will be enough to detect trends in the data, which then can be used for subsequent power calculations for a larger adequately powered clinical trial.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/07/2019
Actual
23/08/2019
Date of last participant enrolment
Anticipated
20/09/2019
Actual
18/09/2019
Date of last data collection
Anticipated
14/12/2019
Actual
22/12/2019
Sample size
Target
140
Accrual to date
Final
76
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 26325 0
2522 - University Of Wollongong
Recruitment postcode(s) [2] 26445 0
2519 - Balgownie
Recruitment postcode(s) [3] 26446 0
2517 - Woonona
Recruitment postcode(s) [4] 26448 0
2518 - Corrimal
Recruitment postcode(s) [5] 26449 0
2515 - Coledale
Recruitment postcode(s) [6] 26450 0
2516 - Bulli
Recruitment postcode(s) [7] 26451 0
2528 - Warilla
Recruitment postcode(s) [8] 26452 0
2527 - Albion Park Rail
Recruitment postcode(s) [9] 26453 0
2500 - Wollongong
Recruitment postcode(s) [10] 26454 0
2529 - Shellharbour
Recruitment postcode(s) [11] 26455 0
2525 - Figtree
Recruitment postcode(s) [12] 26456 0
2526 - Cordeaux Heights
Recruitment postcode(s) [13] 26457 0
2502 - Cringila
Recruitment postcode(s) [14] 26458 0
2506 - Berkeley
Recruitment postcode(s) [15] 26459 0
2530 - Dapto
Recruitment postcode(s) [16] 26460 0
2505 - Port Kembla
Recruitment postcode(s) [17] 26461 0
2502 - Primbee
Recruitment postcode(s) [18] 27154 0
2541 - Nowra East
Recruitment postcode(s) [19] 27155 0
2540 - Sanctuary Point
Recruitment postcode(s) [20] 27156 0
2535 - Shoalhaven Heads

Funding & Sponsors
Funding source category [1] 302494 0
University
Name [1] 302494 0
University of Wollongong
Country [1] 302494 0
Australia
Funding source category [2] 302729 0
Commercial sector/Industry
Name [2] 302729 0
Nu-Mega Ingredients Pty Ltd
Country [2] 302729 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
University of Wollongong, Northfields Ave, Wollongong, NSW, 2522
Country
Australia
Secondary sponsor category [1] 302397 0
None
Name [1] 302397 0
Address [1] 302397 0
Country [1] 302397 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303151 0
University of Wollongong Human Research Ethics Committee
Ethics committee address [1] 303151 0
Research Services Office
Building 20, Level 1
University of Wollongong,
Northfields Ave
Wollongong NSW 2522
Ethics committee country [1] 303151 0
Australia
Date submitted for ethics approval [1] 303151 0
16/04/2019
Approval date [1] 303151 0
25/06/2019
Ethics approval number [1] 303151 0
2019/171

Summary
Brief summary
The aim of the Omega Kid Study is to investigate the effect of omega-3 supplementation on behavioural outcomes such as self-regulation and executive function in preschool aged children. The study is parallel in design and placebo controlled with the intervention period lasting 12 weeks. Assessments will be conducted at baseline and at 12 weeks, after the intervention period. It is hypothesised that children who receive an active omega-3 supplement will show improvements in self-regulation and executive function, when compared to a matched placebo control group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92654 0
Prof Mitch Byrne
Address 92654 0
Bld 41 Rm 41.154a Office of the DVC Health & Communities University of Wollongong, Northfields Ave, NSW, 2522, Australia
Country 92654 0
Australia
Phone 92654 0
+61 2 42215310
Fax 92654 0
Email 92654 0
[email protected]
Contact person for public queries
Name 92655 0
Miss Lauren Roach
Address 92655 0
Bld 41 Rm 41.309B School of Medicine University of Wollongong, Northfields Ave, NSW, 2522, Australia
Country 92655 0
Australia
Phone 92655 0
+61 2 42213535
Fax 92655 0
Email 92655 0
[email protected]
Contact person for scientific queries
Name 92656 0
Miss Lauren Roach
Address 92656 0
Bld 41 Rm 41.309B School of Medicine University of Wollongong, Northfields Ave, NSW, 2522, Australia
Country 92656 0
Australia
Phone 92656 0
+61 2 42213535
Fax 92656 0
Email 92656 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
EmbaseEffect of omega-3 supplementation on self-regulation in typically developing preschool-aged children: Results of the omega kid pilot study-a randomised, double-blind, placebo-controlled trial.2021https://dx.doi.org/10.3390/nu13103561
EmbaseThe feasibility of the "omega kid" study protocol: A double-blind, randomised, placebo-controlled trial investigating the effect of omega-3 supplementation on self-regulation in preschool-aged children.2021https://dx.doi.org/10.3390/nu13010213
N.B. These documents automatically identified may not have been verified by the study sponsor.