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Trial registered on ANZCTR


Registration number
ACTRN12607000332426
Ethics application status
Approved
Date submitted
19/06/2007
Date registered
20/06/2007
Date last updated
17/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Omega-3 fatty acids for ADHD symptoms and learning difficulties in children
Scientific title
Randomised controlled trial investigating effect of supplementation with omega-3 fatty acids EPA and DHA versus omega-6 fatty acid LA on ADHD symptoms and learning difficulties in 7-12 year old children
Secondary ID [1] 287905 0
Nil known
Universal Trial Number (UTN)
Trial acronym
N3AD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention deficit hyperactivity disorder, learning difficulties in 7-12 year old children 1881 0
Condition category
Condition code
Neurological 1975 1975 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This double-blind trial will supplement children with 1g eicosapentaenoic acid (EPA), 1g of docosahexaenoic acid (DHA) or linolenic acid (LA; sunflower oil placebo) in capsule format (4 capsules per day) in a 3 x 3 crossover trial over 12 months. It is expected that 4 months on each oil will provide a sufficient washout from the previous oil.
Intervention code [1] 1841 0
Treatment: Other
Comparator / control treatment
Linolenic acid (LA; sunflower oil placebo)
Control group
Placebo

Outcomes
Primary outcome [1] 2793 0
Conners Parent Rating Scales
Timepoint [1] 2793 0
Measured at 0, 4, 8 and 12 months.
Primary outcome [2] 2794 0
Cognitive assessments of attention, impulsivity and literacy
Timepoint [2] 2794 0
Measured at 0, 4, 8 and 12 months.
Primary outcome [3] 2795 0
Erythrocyte omega-3 fatty acid levels
Timepoint [3] 2795 0
Measured at 0, 4, 8 and 12 months.
Secondary outcome [1] 4714 0
Phospholipase enzyme (PLA2) activity
Timepoint [1] 4714 0
Measured at baseline.
Secondary outcome [2] 4715 0
Eicosanoid levels
Timepoint [2] 4715 0
Measured at baseline.

Eligibility
Key inclusion criteria
Children, ADHD diagnosis, parent-reported learning difficulties, willing to fufil requirements of the study.
Minimum age
7 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cannot be on stimulant medication, cannot have taken omega-3 supplements for up to 3 months, must not have haemophilia.

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 concealment will be done by receipt of numbered containers by the manufacturer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Children will be stratified according to age and gender then block randomised in using PEPI computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
All participants and researchers (including the people administering the treatment/s, the people assessing the outcomes, the people analysing the results/data, and data entry) will be blinded to the treatments.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/07/2007
Actual
21/06/2007
Date of last participant enrolment
Anticipated
Actual
6/06/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
90
Recruitment in Australia
Recruitment state(s)
QLD,SA

Funding & Sponsors
Funding source category [1] 2115 0
Government body
Name [1] 2115 0
Australian Research Council Linkage grant (APDI)
Country [1] 2115 0
Australia
Funding source category [2] 2116 0
Commercial sector/Industry
Name [2] 2116 0
Industry partner Novasel Australia
Country [2] 2116 0
Australia
Funding source category [3] 2117 0
Charities/Societies/Foundations
Name [3] 2117 0
Australian Technology Network (ATN) Centre for Metabolic Fitness
Country [3] 2117 0
Australia
Funding source category [4] 2118 0
Government body
Name [4] 2118 0
South Australian (SA) Health Department (PhD scholarship)
Country [4] 2118 0
Australia
Primary sponsor type
University
Name
Nutritional Physiology Research Centre, University of South Australia
Address
University of South Australia
GPO Box 2471
Adelaide SA 5001
Australia
Country
Australia
Secondary sponsor category [1] 1924 0
University
Name [1] 1924 0
Queensland University of Technology
Address [1] 1924 0
60 Musk Avenue
Kelvin Grove Urban Village
Kelvin Grove, Queensland, 4059
Country [1] 1924 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3907 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 3907 0
Ethics committee country [1] 3907 0
Australia
Date submitted for ethics approval [1] 3907 0
Approval date [1] 3907 0
31/05/2007
Ethics approval number [1] 3907 0
P045/07
Ethics committee name [2] 3908 0
QUT
Ethics committee address [2] 3908 0
Ethics committee country [2] 3908 0
Australia
Date submitted for ethics approval [2] 3908 0
Approval date [2] 3908 0
Ethics approval number [2] 3908 0

Summary
Brief summary
The principal aim of this project is to investigate effects of supplementation with the omega-3 (n-3) polyunsaturated fatty acids (PUFA) EPA and DHA on symptoms of attention deficit hyperactivity disorder (ADHD), specifically hyperactivity, impulsivity, inattention and cognitive problems, in 7-12 year old children. We also aim to investigate blood fatty acid profiles before, during and after the intervention. This 12-month controlled intervention trial will be conducted in Adelaide and Brisbane in 2007/08.
Trial website
Trial related presentations / publications
Milte CM, Sinn N*, Buckley JD, Coates AM, Young R, Howe PRC (2011). Polyunsaturated fatty acids, cognition and literacy in children with ADHD with and without learning difficulties. Journal of Child Health Care. 15(4):299-311.

Milte C, Parletta N*, Buckley JD, Coates AM, Young RM, Howe PRC (2012). Eicosapentaenoic and docosahexaenoic acids, cognition and behavior in children with attention deficit/hyperactivity disorder: A randomised controlled trial. Nutrition, 28(6):670-677.

Milte CM, Parletta N*, Buckley JD, Coates AM, Young RM, Howe PRC (2015). Increased erythrocyte eicosapentaenoic acid and docosahexaenoic acid are associated with improved attention and behaviour in children with ADHD in a 12-month randomised controlled three-way crossover trial. Journal of Attention Disorders. 19(11):954-964
Public notes

Contacts
Principal investigator
Name 27655 0
Dr Natalie Parletta
Address 27655 0
University of South Australia
GPO Box 2471, CEA-08
Adelaide SA 5001
Country 27655 0
Australia
Phone 27655 0
+61883021757
Fax 27655 0
Email 27655 0
[email protected]
Contact person for public queries
Name 11030 0
Dr Natalie Sinn
Address 11030 0
Nutritional Physiology Research Centre
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country 11030 0
Australia
Phone 11030 0
+61 8 83021757
Fax 11030 0
+61 8 83022178
Email 11030 0
[email protected]
Contact person for scientific queries
Name 1958 0
Dr Natalie Sinn
Address 1958 0
Nutritional Physiology Research Centre
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country 1958 0
Australia
Phone 1958 0
+61 8 83021757
Fax 1958 0
+61 8 83022178
Email 1958 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

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