Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000539336
Ethics application status
Approved
Date submitted
6/04/2017
Date registered
13/04/2017
Date last updated
10/03/2020
Date data sharing statement initially provided
8/04/2019
Date results information initially provided
8/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Omega-3 supplements in gout
Scientific title
Omega three fatty acid supplementation in gout: effect on serum urate, flare rate and weight
Secondary ID [1] 291623 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 302747 0
Condition category
Condition code
Musculoskeletal 302263 302263 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Omega-3 oil 2.6gm daily by mouth for six months. Adherence will be monitored by volume of oil returned and by blood omega three fatty acid levels
Intervention code [1] 297697 0
Treatment: Other
Comparator / control treatment
Control group receive no omega-three supplement and usual care as by the treating physician
Control group
Active

Outcomes
Primary outcome [1] 301675 0
The primary efficacy outcome measure will be change in serum urate
Timepoint [1] 301675 0
Month 6
Secondary outcome [1] 333533 0
Change in weight between months 0 and 6 as measured on scales
Timepoint [1] 333533 0
six months
Secondary outcome [2] 333558 0
Mean number of self reported gout flares
Timepoint [2] 333558 0
Six months
Secondary outcome [3] 333559 0
Percentage of participants with self reported gout flare
Timepoint [3] 333559 0
At each month for six months from study entry
Secondary outcome [4] 333560 0
Need for medication to treat gout flares as reported by patient and review of medical records
Timepoint [4] 333560 0
At six months
Secondary outcome [5] 333561 0
Cessation of fish oil due to adverse effects such as nausea, heartburn. Adverse effects will be assessed by patient questionnaire designed for this study
Timepoint [5] 333561 0
Six months
Secondary outcome [6] 333562 0
Requirement for change in urate lowering therapy medication use as reported by patient and review of medical records
Timepoint [6] 333562 0
Six months
Secondary outcome [7] 333585 0
Time to first gout flare during the study period
Timepoint [7] 333585 0
Gout flares reported by patient captured at time it occurs during the six month study period
Secondary outcome [8] 333586 0
Change in plasma oxypurinol concentration
Timepoint [8] 333586 0
Assessed at six months by blood test

Eligibility
Key inclusion criteria
Age over 18 years
Gout according to the 2015 ACR/EULAR criteria
Ability to give informed consent
Ability to communicate via telephone
Stable dose of allopurinol for at least one month
Serum urate >0.36mmol/l at screening
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous intolerance or allergy with omega-3 fatty acid supplementation
Unstable co-morbid health conditions
Unable to comply with study procedures
Already taking at least 2gm daily of omega-3 supplements
Not willing to remain off omega-3 supplements if randomised to control arm
Allergy to fish or shell fish
Implantable defibrillator
Current use of warfarin or dabigatrin

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomised on a 1:1 ratio to receive omega-3 fatty acid supplementation or not. The randomisation list will be generated by the independent study statistician using a computer generated list and will be arranged in permuted blocks. Randomisation will occur at the baseline visit.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
No interim efficacy or safety analyses are intended. All baseline demographic and clinical features will be summarized by randomized groups using means, medians, standard deviations ranges and frequencies and percentages as appropriate. No formal hypothesis testing will be undertaken on the baseline measurements. The change in serum urate (primary outcome), weight and oxypurinol concentration from baseline to 6 months will be compared between randomized groups using ANCOVA with the relevant baseline level used as the covariate. The means changes and the difference in the mean change will be summarized with 95% confidence intervals. The mean number of flares will be compared between groups using the non-parametric Mann-Whitney U-test. The percentage of participants; with flares and needing rescue therapy will be compared between randomized groups using fisher’s exact tests. The time to first flare will be summarized using Kaplan-Meier estimates and compared between randomised groups using the log-rank test. All analyses will be undertaken SPSS. All tests will be two-tailed and a 5% significance level maintained. Primary data analyses will be performed on the intention-to-treat population, all randomized participants. Secondary analysis will be based on the per-protocol basis which excludes participants with major protocol deviations. There will be no imputation of missing data.
All adverse events and serious adverse events will be tabulated by system/organ class, severity and relatedness by randomized group as both frequency of event and percentage of participants experiencing the event. Key adverse events potentially related to fish oil treatment e.g. nausea, fishy after taste may be compared between randomized groups using Chi-square or Fisher’s exact tests as appropriate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/06/2017
Actual
12/07/2017
Date of last participant enrolment
Anticipated
28/12/2018
Actual
1/11/2018
Date of last data collection
Anticipated
28/06/2019
Actual
28/06/2019
Sample size
Target
40
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 8778 0
New Zealand
State/province [1] 8778 0
Canterbury

Funding & Sponsors
Funding source category [1] 296113 0
Government body
Name [1] 296113 0
Lottery Health New Zealand Department of Internal Affairs
Country [1] 296113 0
New Zealand
Primary sponsor type
University
Name
University of Otago, Christchurch
Address
PO Box 4345 Christchurch 8014, New Zealand
Country
New Zealand
Secondary sponsor category [1] 295010 0
None
Name [1] 295010 0
Address [1] 295010 0
Country [1] 295010 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297367 0
Health and Disability Thics Committee of New Zelaland
Ethics committee address [1] 297367 0
Ministry of Health
P O Box 5013
Wellington
New Zealand
Ethics committee country [1] 297367 0
New Zealand
Date submitted for ethics approval [1] 297367 0
13/04/2017
Approval date [1] 297367 0
31/05/2017
Ethics approval number [1] 297367 0
17/NTB/68

Summary
Brief summary
Management of gout focuses on treating the acute attacks and long-term lowering of serum urate so that acute attacks stop. Gout attacks are common when urate lowering treatments are started so treatment with non-steroidal anti-inflammatories, colchicine or steroids are recommended during the first 6 months of urate lowering therapy. However, each of these drugs has potential adverse effects and are contra-indicated in many people with gout. Omega-3 fatty acids are a “natural non-steroidal anti-inflammatory” and may therefore be an appropriate alternative. This study will provide preliminary evidence required to design a full clinical trial of fish oil in gout.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73830 0
Prof Lisa Stamp
Address 73830 0
Department of Medicine
University of Otago, Christchurch
P.O.Box 4345
Christchurch 8014
Country 73830 0
New Zealand
Phone 73830 0
+6433640253
Fax 73830 0
Email 73830 0
[email protected]
Contact person for public queries
Name 73831 0
Ms Jill Drake
Address 73831 0
Department of Medicine
University of Otago, Christchurch
P.O.Box 4345
Christchurch 8014
Country 73831 0
New Zealand
Phone 73831 0
+6433786088
Fax 73831 0
Email 73831 0
[email protected]
Contact person for scientific queries
Name 73832 0
Prof Lisa Stamp
Address 73832 0
Department of Medicine
University of Otago, Christchurch
P.O.Box 4345
Christchurch 8014
Country 73832 0
New Zealand
Phone 73832 0
+6433640253
Fax 73832 0
Email 73832 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
We do not have ethical approval for this.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1815Ethical approval  [email protected]



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-three supplementation on serum urate and gout flares in people with gout; a pilot randomized trial.2022https://dx.doi.org/10.1186/s41927-022-00263-1
N.B. These documents automatically identified may not have been verified by the study sponsor.