Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000040369
Ethics application status
Approved
Date submitted
3/01/2017
Date registered
10/01/2017
Date last updated
22/08/2019
Date data sharing statement initially provided
22/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Fish Oil Supplements for Recovery after Mild Traumatic Brain Injury (mTBI): A Randomised Control Trial
Scientific title
The Effects of Fish Oil Supplementation on Cognitive Function after Mild Traumatic Brain Injury (mTBI): A Randomised Double Blind Placebo Control Trial
Secondary ID [1] 290824 0
None
Universal Trial Number (UTN)
U1111-1189-5990
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Traumatic Brain Injury 301492 0
Condition category
Condition code
Injuries and Accidents 301203 301203 0 0
Other injuries and accidents
Neurological 301285 301285 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the treatment arm of the trial will swallow four 15mm long soft-gel capsules of fish oil every day for six months. This will equate to a daily dose of 1990mg docosahexaenoic acid (DHA) and 470mg eicosapentaenoic acid (EPA). Participants will be asked to take all four capsules in the morning with breakfast and a glass of water, however the timing may be altered for any participants who do not tolerate this, or do not consume breakfast; the daily dose will not be altered. The supplement will be issued by trained personnel from various Concussion Clinics, with information regarding dose and storage presented in both written and oral format. Participants will be provided with a diary to record when they have taken each dose, and note any potential side effects. They will be contacted via telephone by the lead researcher each month, to discuss tolerance and adherence to the treatment.
Intervention code [1] 296745 0
Treatment: Other
Comparator / control treatment
Participants in the control arm of the trial will swallow four 15mm long soft-gel capsules of sunflower oil every day for six months, equating to a daily dose of 4000mg sunflower oil. These capsules are identical to the fish oil capsules of the treatment arm of the trial. Participants will be asked to take all four capsules in the morning with breakfast and a glass of water, however the timing may be altered for any participants who do not tolerate this, or do not consume breakfast; the daily dose will not be altered. The supplement will be issued by trained personnel from various Concussion Clinics, with information regarding dose and storage presented in both written and oral format. Participants will be provided with a diary to record when they have taken each dose, and note any potential side effects. They will be contacted via telephone by the lead researcher each month, to discuss tolerance and adherence to the treatment.
Control group
Placebo

Outcomes
Primary outcome [1] 300622 0
Change in over all cognitive symptoms, measured using a composite score derived from the following cognitive subtests: Logical memory, digit span forward and backward, verbal fluency, paced auditory serial addition test, and backwards counting. All tests are administered via telephone.
Timepoint [1] 300622 0
Baseline - before intervention, three months after beginning the intervention, completion - six months after beginning the intervention.
Secondary outcome [1] 330427 0
Mood symptoms, assessed using the Depression Anxiety and Stress Scale 21 item version (DASS-21).
Timepoint [1] 330427 0
Baseline - before intervention, three months after beginning the intervention, completion - six months after beginning the intervention.
Secondary outcome [2] 330428 0
Self-reported concussion symptoms, measured by the Rivermead Post-Concussion Symptom Questionnaire (RPQ).
Timepoint [2] 330428 0
Baseline - before intervention, three months after beginning the intervention, completion - six months after beginning the intervention.
Secondary outcome [3] 330429 0
Self-reported post-injury disability, assessed using the Rivermead Head Injury Follow Up Questionnaire (RHFUQ).
Timepoint [3] 330429 0
Trial completion - 6 months after beginning the intervention.
Secondary outcome [4] 330628 0
Change in working memory, assessed using Digit Span Backward
Timepoint [4] 330628 0
Baseline - before intervention, three months after beginning the intervention, completion - six months after beginning the intervention.
Secondary outcome [5] 330629 0
Change in attention assessed using Digit Span Forward
Timepoint [5] 330629 0
Baseline - before intervention, three months after beginning the intervention, completion - six months after beginning the intervention.
Secondary outcome [6] 330630 0
Change in memory performance assessed using Logical Memory.
Timepoint [6] 330630 0
Baseline - before intervention, three months after beginning the intervention, completion - six months after beginning the intervention.
Secondary outcome [7] 330631 0
Change in executive function, assessed using Verbal Fluency
Timepoint [7] 330631 0
Baseline - before intervention, three months after beginning the intervention, completion - six months after beginning the intervention.
Secondary outcome [8] 330632 0
Change in speed of processing, assessed using backwards counting and the Paced Auditory Serial Addition Test.
Timepoint [8] 330632 0
Baseline - before intervention, three months after beginning the intervention, completion - six months after beginning the intervention.

Eligibility
Key inclusion criteria
Individuals who have suffered a mTBI and are experiencing difficulty with one or more of the following cognitive domains will be eligible for inclusion: memory, attention, concentration, processing speed, and/or executive function. Participants must also be fluent in the English language, have access to a telephone and a distraction free environment for one hour every three months, and be able to hear clearly over the telephone.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals who are already taking fish oil, have taken fish oil in the last 6 months, or consume more than 3 servings of oily fish per week will be excluded. Anyone who has had recent surgery or is suffering from significant peripheral injury, is taking medication that affects cognitive function, or has any mental or neurological disorder that affects cognition will not be eligible to participate. Additionally, those with seafood allergy, aversion to fish/beef gelatin, difficulty swallowing capsules, or women who are pregnant or breastfeeding will be ineligible.

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)
Bottles of capsules will be randomly assigned a study number, and have the identifying serial number removed before being transported to the participating Concussion Clinics. Equal amounts of treatment and placebo will be assigned to each clinic, and a random list of the order of allocation will also be provided. A trained research assistant will conduct the randomisation and seal a list of which study numbers correspond to the treatment and placebo groups in an envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer software - random.org
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
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A power analysis was conducted to calculate the minimum sample size needed. To detect an effect size of partial eta squared =.02 and provide a statistical power equal to 0.8 at an a level of .05, a minimum sample size of 82 participants is required. In order to utilise the full amount of available supplement, 96 participants will be recruited.

Independent samples T-tests will be used to test for equivalence between groups on all dependent measures at baseline.

One way mixed between-within analysis of variance (ANOVA) tests will analyse the outcome variables. The between subjects factor for this model will be the group at two levels: treatment and control. The within subjects factor will be the outcome measures at baseline, time two, and time three. Such models will be created for each outcome variable.

Correlation analysis will be used to examine the relationship between injury beliefs and outcome.

Data will be analysed using the latest available version of SPSS for Windows.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/02/2017
Actual
26/04/2017
Date of last participant enrolment
Anticipated
31/05/2017
Actual
29/11/2017
Date of last data collection
Anticipated
30/11/2017
Actual
29/11/2017
Sample size
Target
96
Accrual to date
Final
12
Recruitment outside Australia
Country [1] 8539 0
New Zealand
State/province [1] 8539 0

Funding & Sponsors
Funding source category [1] 295250 0
University
Name [1] 295250 0
Massey University
Country [1] 295250 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Massey University Wellington
PO Box 756
Wellington
6140
New Zealand
Country
New Zealand
Secondary sponsor category [1] 294079 0
None
Name [1] 294079 0
Address [1] 294079 0
Country [1] 294079 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296589 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 296589 0
Health and Disability Ethics Committees
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 296589 0
New Zealand
Date submitted for ethics approval [1] 296589 0
17/11/2016
Approval date [1] 296589 0
19/12/2016
Ethics approval number [1] 296589 0
16/NTA/206

Summary
Brief summary
Mild Traumatic Brain Injury (mTBI), also known as concussion, is a major public health problem for many countries. In New Zealand, over 90% of traumatic brain injuries are mild and occur most frequently as a result of falls, motor vehicle accidents, and assaults. The symptoms of mTBI can last anywhere from days to several months, or even years, after the initial incident. Symptoms may be physical (e.g. dizziness, headaches) emotional (e.g. anxiety, depression), and/or cognitive (e.g. difficulty with memory, attention, and processing speed). Naturally, many individuals struggle to perform the duties of their work and/or everyday life while suffering such symptoms, thus effective treatments are being sought. Fish oil is a commonly consumed over-the-counter nutritional supplement that may be effective for treating the symptoms of mTBI. Docosahexaenoic acid (DHA), a key component of fish oil, is the most abundant lipid in the human brain. It is important for brain development, both the structure and function of mature brain cells, and has shown efficacy at treating mTBI in rodents, as well as enhancing cognition in human adults. This supplement has not yet been the focus of a randomised control trial for treating mTBI in humans, which is necessary before it can be considered an effective treatment. For the present study, 96 mTBI sufferers will be assigned to either the treatment group consuming 4g fish oil (1990mg DHA) per day, or the control group consuming 4g sunflower oil per day, for six months. Participants will undergo cognitive testing and mood screening via telephone at baseline, three months, and six months before results are analysed for change over time and groups are compared. It is hypothesised that the fish oil group will display fewer mTBI symptoms than the placebo group at the three month and six month time points, thus exhibiting a quicker recovery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71390 0
Ms Brylee Cresswell
Address 71390 0
C/O Massey University Psychology Clinic
PO Box 756
Wellington 6140
Country 71390 0
New Zealand
Phone 71390 0
+6448010492
Fax 71390 0
Email 71390 0
[email protected]
Contact person for public queries
Name 71391 0
Ms Brylee Cresswell
Address 71391 0
C/O Massey University Psychology Clinic
PO Box 756
Wellington 6140
Country 71391 0
New Zealand
Phone 71391 0
+6448010492
Fax 71391 0
Email 71391 0
[email protected]
Contact person for scientific queries
Name 71392 0
Ms Brylee Cresswell
Address 71392 0
C/O Massey University Psychology Clinic
PO Box 756
Wellington 6140
Country 71392 0
New Zealand
Phone 71392 0
+6448010492
Fax 71392 0
Email 71392 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
Participants did not consent to individual data sharing, minimal data was collected, and no analyses are planned.


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
No additional documents have been identified.