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Trial registered on ANZCTR


Registration number
ACTRN12613000734763
Ethics application status
Approved
Date submitted
28/06/2013
Date registered
2/07/2013
Date last updated
16/11/2018
Date data sharing statement initially provided
16/11/2018
Date results information initially provided
16/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
O'Mega Man Study: an investigation of fish oil and micronutrient supplementation on aggressive behaviour in a sample of inmates in a NSW Correctional Centre
Scientific title
Effect of fish oil and micronutrient supplementation on aggressive behaviour of adult offenders: a Randomised Control Trial (RCT) pilot and feasibility study
Secondary ID [1] 282762 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health 289502 0
Condition category
Condition code
Mental Health 289831 289831 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tuna Oil capsules ( 3 x 1g capsules per day for 16 weeks) AND
Multi-vitamins and minerals (1 tablet per day for 16 weeks) The multi-vitamins tablet contains the following:
Vitamin A (as retinyl palmitate) 750 IU
Thiamin hydrochloride (vitamin B1) 50mg
Riboflavin (vitamin B2) 20mg
Nicotinic acid (vitamin B3) 10mg
Nicotinamide (vitamin B3) 200mg
Pantothenic acid (as calcium salt) (vitamin B5) 100mg
Pyridoxine hydrochloride (vitamin B6) 50mg
Cyanocobalamin (vitamin B12) 100mcg
Ascorbic acid (vitamin C) 50mg
Vitamin D3 (cholecalciferol) 100 IU
Vitamin E (as d-alpha tocopherol acid succinate) 25 IU
Betacarotene 3mg
Biotin 20mcg
Folic Acid (vitamin B9) 150mcg
Calcium (as amino acid chelate) 10mg
Cobalt (as chloride) 25mcg
Copper (as amino acid chelate) 6mcg
Lithium (as carbonate) 140mcg
Magnesium (as L-aspartate and phosphate) 7.6mg
Manganese (as sulphate) 93mcg
Potassium (as L-aspartate) 2mg
Potassium (as di-hydrogen phosphate) 13.6mg
Zinc (as gluconate) 1.3mg
Zinc (as sulphate) 7.6mg
Amino-benzoic acid 20mg
Choline bi-tartrate 50mg
Inositol 25mg
Scutellaria lateriflora (Equiv. dry herb) 100mg
Valeriana officinalis (Equiv. dry root) 100mg
L-Glutamine 50mg
Lysine hydrochloride 10mg
Betaine hydrochloride 10mg

Administered simultaneously
One week supply will be provided in a blister pack and the empty blister pack is returned prior to receiving the next week's supply
Intervention code [1] 287428 0
Treatment: Other
Intervention code [2] 287429 0
Behaviour
Comparator / control treatment
Sunola Oil capsules (3 x 1g capsules per day for 16 weeks) AND Multi-vitamins and minerals (1 tablet per day for 16 weeks) The multi-vitamins tablet contains the following: Vitamin A (as retinyl palmitate) 750 IU Thiamin hydrochloride (vitamin B1) 50mg Riboflavin (vitamin B2) 20mg Nicotinic acid (vitamin B3) 10mg Nicotinamide (vitamin B3) 200mg Pantothenic acid (as calcium salt) (vitamin B5) 100mg Pyridoxine hydrochloride (vitamin B6) 50mg Cyanocobalamin (vitamin B12) 100mcg Ascorbic acid (vitamin C) 50mg Vitamin D3 (cholecalciferol) 100 IU Vitamin E (as d-alpha tocopherol acid succinate) 25 IU Betacarotene 3mg Biotin 20mcg Folic Acid (vitamin B9) 150mcg Calcium (as amino acid chelate) 10mg Cobalt (as chloride) 25mcg Copper (as amino acid chelate) 6mcg Lithium (as carbonate) 140mcg Magnesium (as L-aspartate and phosphate) 7.6mg Manganese (as sulphate) 93mcg Potassium (as L-aspartate) 2mg Potassium (as di-hydrogen phosphate) 13.6mg Zinc (as gluconate) 1.3mg Zinc (as sulphate) 7.6mg Amino-benzoic acid 20mg Choline bi-tartrate 50mg Inositol 25mg Scutellaria lateriflora (Equiv. dry herb) 100mg Valeriana officinalis (Equiv. dry root) 100mg L-Glutamine 50mg Lysine hydrochloride 10mg Betaine hydrochloride 10mg Administered simultaneously. One week supply will be provided in a blister pack and the empty blister pack is returned prior to receiving the next week's supply
Control group
Placebo

Outcomes
Primary outcome [1] 289897 0
Aggressive Behaviour will be assessed by the number of reports recorded in the Correctional Centre AND a rating system of behaviour will be applied to the individual study participants case notes
Timepoint [1] 289897 0
at baseline and 4 months after randomisation
Secondary outcome [1] 303508 0
Aggressive cognitions will be assessed by the Aggression Questionnaire
Timepoint [1] 303508 0
at baseline and 4 months after randomisation
Secondary outcome [2] 303534 0
Attention Deficit Disorder will be assessed using the Brown's Attention Deficit Disorder
Timepoint [2] 303534 0
at baseline and 4 months after randomisation

Eligibility
Key inclusion criteria
Resident of South Coast Correctional Centre and minimum stay of 4 months
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Erythrocyte EPA and DHA of greater than 6% of total fatty acids

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 287531 0
University
Name [1] 287531 0
University of Wollongong
Address [1] 287531 0
Northfields Ave
Wollongong
NSW 2522
Country [1] 287531 0
Australia
Funding source category [2] 287532 0
Government body
Name [2] 287532 0
Department of Corrective Services, NSW
Address [2] 287532 0
GPO Box 31, Sydney NSW 2001
Country [2] 287532 0
Australia
Funding source category [3] 287533 0
Commercial sector/Industry
Name [3] 287533 0
Nu Mega Ingredients
In kind support of fish oil and sunola oil capsules
Address [3] 287533 0
31 PINNACLE ROAD, ALTONA NORTH, 3025, VICTORIA, AUSTRALIA
Country [3] 287533 0
Australia
Funding source category [4] 287534 0
Commercial sector/Industry
Name [4] 287534 0
Nutrition Care Pharmaceuticals Pty Ltd
In kind support of the multi-vitamins and minerals
Address [4] 287534 0
25 - 31 Keysborough Avenue
Keysborough, Victoria 3173, Australia
Country [4] 287534 0
Australia
Primary sponsor type
Individual
Name
Barbara Meyer
Address
School of Medicine and Health
University of Wollongong
Northfields Ave
Wollongong
NSW 2522
Country
Australia
Secondary sponsor category [1] 286286 0
None
Name [1] 286286 0
Address [1] 286286 0
Country [1] 286286 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301953 0
University of Wollongong Human Research Ethics Committee
Ethics committee address [1] 301953 0
Northfields Ave
Wollongong
NSW 2522
Ethics committee country [1] 301953 0
Australia
Date submitted for ethics approval [1] 301953 0
28/11/2012
Approval date [1] 301953 0
21/02/2013
Ethics approval number [1] 301953 0
NSA13/004

Summary
Brief summary
The primary purpose of this study is to assess the feasibility of conducting a placebo controlled trial in the Corrective Services setting and also to generate pilot data for use in the application of funding for a multi-centre trial in due course.
It is expected that the fish oil plus micronutrients supplemented group will have reduced aggressive behaviour comapred to the placebo group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41138 0
A/Prof Barbara Meyer
Address 41138 0
School of Medicine and Health
University of Wollongong
Northfields Ave
Wollongong NSW 2522
Country 41138 0
Australia
Phone 41138 0
+61 2 4221 3459
Fax 41138 0
Email 41138 0
bmeyer@uow.edu.au
Contact person for public queries
Name 41139 0
A/Prof Barbara Meyer
Address 41139 0
School of Medicine and Health
University of Wollongong
Northfields Ave
Wollongong NSW 2522
Country 41139 0
Australia
Phone 41139 0
+61 2 4221 3459
Fax 41139 0
Email 41139 0
bmeyer@uow.edu.au
Contact person for scientific queries
Name 41140 0
A/Prof Barbara Meyer
Address 41140 0
School of Medicine and Health
University of Wollongong
Northfields Ave
Wollongong NSW 2522
Country 41140 0
Australia
Phone 41140 0
+61 2 4221 3459
Fax 41140 0
Email 41140 0
bmeyer@uow.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Other publications
Have study results been made publicly available in another format?
No
Results – plain English summary
This study showed that it was feasible to conduct research in a Correctional Centre facility. The baseline data showed that the higher the blood omega-3 levels the lower the levels of aggressive behaviour and the lower scores of attention deficit disorders.