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Trial registered on ANZCTR


Registration number
ACTRN12616000220460
Ethics application status
Approved
Date submitted
17/12/2014
Date registered
18/02/2016
Date last updated
18/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of omega-3 fatty acids on offending behavior in repeat violent offenders : A Randomised Controlled Trial feasibility study
Scientific title
Effect of omega-3 fatty acids on offending behavior in repeat violent offenders: A Randomised Controlled Trial feasibility study
Secondary ID [1] 285864 0
Nil
Universal Trial Number (UTN)
U1111-1165-2952
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Impulsivity 293776 0
Violence 293777 0
Self reported recidivism 293778 0
Condition category
Condition code
Mental Health 294083 294083 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 294084 294084 0 0
Other mental health disorders
Alternative and Complementary Medicine 294356 294356 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This pilot study will utilise a double-blind, randomised, placebo-controlled trial of omega-3 supplementation in 50 men who have been convicted of violent crimes in NSW. Upon entry into the study, participants will be randomised into either the treatment (n=25) or placebo (n=25) arm of the study.

Treatment
Participants enrolled in the study will take 5 x 1gm capsules orally per day for three months. Those receiving the active treatment will receive 5 x 1g fish oil capsules, containing a total of 3000mg LC-omega-3 FA (2000mg EPA, 1000mg DHA) taken once daily for 3 months.

Adherence will be assessed using both direct questioning by the research assistant, pill counting, and erythrocyte omega-3 content based on blood omega-3 levels. Participants will be required to return empty medication packs at the follow-up assessments (6 and 12 weeks) and asked to provide a blood sample at baseline and 12 weeks for measurement of omega-3 content in erythrocyte membrane phospholipids. Participants will also be asked during the follow-up phone calls how many days they have missed taking their capsules. Participants will also be asked to return the capsules at each face-to-face meeting with the research assistant, the remaining number of capsules will then be counted.
Intervention code [1] 290843 0
Treatment: Other
Comparator / control treatment
Placebo

The placebo capsules hold the equivalent amount of oil to the fish oil capsules (1g/capsule) but are negligible LC-omega-3 FAs. All capsules will be matched in appearance,
and are encased with an enteric coating which is extremely efficient at dampening the flavour of the contents.
Control group
Placebo

Outcomes
Primary outcome [1] 293869 0
Adherence to using omega 3 supplementation in a community sample of impulsive, repeat-violent offenders.
Weeks (1,3, 9, ) Telephone Call: Omega 3 supplementation adherence, compliance issues.
Baseline, Weeks (6, 12) Face to face interviews,

Omega 3 index levels will be assessed after collecting a drop of blood via a finger prick kit. The dried blood spot will be analysed using commercial techniques at OmegaQuant, LLC U.S.A
Timepoint [1] 293869 0
Weeks (1,3,9,12)

Baseline, weeks 6, 12
Secondary outcome [1] 312047 0
Impulsivity
Assessed using Barratt Impulsivity Scale (BIS-15)
Timepoint [1] 312047 0
Baseline, Weeks 6, 12
Secondary outcome [2] 312209 0
Anger
Assessed using: AIAQ - Anger, Irritability and Aggression Questionnaire, STAXI-2 - State Trait Anger Expression Inventory
Timepoint [2] 312209 0
Assessed: Baseline, Weeks 6, 12
Secondary outcome [3] 312210 0
Depression
Assessed using Beck Depression Inventory, Kessler Psycholoical Distress Scale
Timepoint [3] 312210 0
Baseline, Weeks 6, 12
Secondary outcome [4] 312211 0
Irritability
Assessed by Anger, Irritability and Aggression Questionnaire (AIAQ)
Timepoint [4] 312211 0
Baseline, Weeks 6, 12
Secondary outcome [5] 312212 0
Self reported recidivism
Criminality Scale of the Opiate Treatment Index
Timepoint [5] 312212 0
Baseline, Week 12

Eligibility
Key inclusion criteria
*Male
*Aged 18 years and over
*Prior conviction for at least two violent offences (e.g. manslaughter, robbery, assault)
*Minimum score of 70 on the Barratt Impulsivity Scale
*Medically fit
*Able to provide informed consent
*Fluent in English
*Willing to provide a sample of blood at the beginning and end of the study
*For the purposes of this study, violent crime is defined as per the Australian Standard Offence Classification and includes the following five categories: homicide (including manslaughter); acts intended to cause injury; dangerous and negligent acts endangering persons; abduction, harassment and other offences against the person; and robbery, extortion and related offences
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
*Allergy to seafood or iodine
*Current use of anti-coagulants and blood thinners
*Current use of systemic antibiotics or anti-inflammatories
*Unstable use of medication to modify mood, behaviour or serotonin levels
*Unwilling to provide a sample of blood at the beginning and end of the study
*Severe mental illness (schizophrenia, bipolar disorder, major depression)
*Considered to be at high risk of suicide
*Significant renal or hepatic impairment
*Anticipation of receiving a custodial sentence
*Impending deportation, moving interstate or to a remote area.
*Conviction for murder or child sex offences

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)
This pilot study will utilise a double blind, randomised, placebo controlled trial of omega 3 supplementation in 50 men who have been convicted of violent crimes in NSW. Upon entry into the study, participants will be randomised into either the treatment (n=25) or placebo (n=25) arm of the study. The randomisation and manufacturing of capsules will be by a TGA-approved manufacturer of clinical trial products. Research assistants interviewing and administering the capsules will be blinded to the treatment allocation. Allocation will be concealed by numbered containers, randomisation by computer, and the holder of the allocation schedule is off site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed by a TGA approved manufacturer of clinical trial products. Permuted block randomisation will be used to allocate subjects into different groups (treatment arms).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Participants must all meet the same eligibility criteria. However 25 participants will receive the Omega-3 product while the other 25 receive a placebo. Each participant will be followed for 12 weeks from entry into study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations were based on several studies conducted in populations highly comparable to our proposed sample. Gesch (2002), Hamazaki (1997, 2005) Hallahan (2007). Stong empirical evidence of 24 substance abusers in a community based sample demonstrated statistical significance to medication adherence. (Buydens-Branchey)

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/02/2015
Date of last participant enrolment
Anticipated
Actual
30/09/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
44
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 9064 0
2300 - Newcastle

Funding & Sponsors
Funding source category [1] 290446 0
University
Name [1] 290446 0
University of NSW
Country [1] 290446 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Mental Health Neuropsychiatry Service
Address
PO Box 833, Newcastle NSW 2300
Country
Australia
Secondary sponsor category [1] 289152 0
University
Name [1] 289152 0
Justice Health Research ProgramThe Kirby Institute, UNSW Australia
Address [1] 289152 0
UNSW
The Kirby Institute
Wallace Wurth Building, Sydney NSW 2052
Country [1] 289152 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292120 0
Hunter New England Research Ethics Committee
Ethics committee address [1] 292120 0
Ethics committee country [1] 292120 0
Australia
Date submitted for ethics approval [1] 292120 0
20/08/2014
Approval date [1] 292120 0
05/11/2014
Ethics approval number [1] 292120 0
14/08/20/4.06

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

Contacts
Principal investigator
Name 53606 0
A/Prof Peter Schofield
Address 53606 0
Hunter New England Mental Health
Neuropsychiatry Service
PO BOX 833
Newcastle, NSW 2300
Country 53606 0
Australia
Phone 53606 0
61 2 4033 5695
Fax 53606 0
Email 53606 0
Peter.Schofield@hnehealth.nsw.gov.au
Contact person for public queries
Name 53607 0
Laura Miles
Address 53607 0
Hunter New England Mental Health
Neuropsychiatry Service
PO BOX 833
Newcastle, NSW 2300
Country 53607 0
Australia
Phone 53607 0
61 2 4033 5701
Fax 53607 0
Email 53607 0
Laura.Miles@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 53608 0
Tony Butler
Address 53608 0
The Kirby Institute, UNSW Australia
Wallace Wurth Building, Sydney NSW 2052
Country 53608 0
Australia
Phone 53608 0
61 2 9385 9257
Fax 53608 0
Email 53608 0
tbutler@kirby.unsw.edu.au

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
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Documents added automatically
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