Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000770268
Ethics application status
Approved
Date submitted
5/10/2017
Date registered
8/05/2018
Date last updated
9/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Krill Oil in Gout
Scientific title
A Randomized controlled trial of of krill oil on ultrasound detected inflammation in people with gout
Secondary ID [1] 293074 0
Nil know
Universal Trial Number (UTN)
U1111-1203-2300
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gout 305006 0
Condition category
Condition code
Inflammatory and Immune System 304361 304361 0 0
Other inflammatory or immune system disorders
Musculoskeletal 304362 304362 0 0
Other muscular and skeletal disorders
Alternative and Complementary Medicine 304363 304363 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Krill oil 1gm twice daily for 12 weeks
oral capsule.
Pill count will be used to check compliance.
Intervention code [1] 299314 0
Treatment: Drugs
Intervention code [2] 299336 0
Treatment: Other
Comparator / control treatment
oral colchicine 500mcg daily for 12 weeks
tablets orally.
Pill count will be used to check compliance.
Control group
Active

Outcomes
Primary outcome [1] 303589 0
Intra articular inflammation as defined as Ultrasound detected power Doppler signal in the joints of people with gout
Timepoint [1] 303589 0
12 weeks post intervention commencement
Secondary outcome [1] 339509 0
Change in serum CRP , measured from blood tests.
Timepoint [1] 339509 0
12 weeks post intervention commencement
6 weeks post intervention commencement
Secondary outcome [2] 339510 0
Change in patient global pain VAS where 0 = no pain and 10 = worst pain imaginable
Timepoint [2] 339510 0
12 weeks post intervention commencement
6 weeks post intervention commencement
Secondary outcome [3] 339511 0
Change in patient global health VAS where 0 = no health problems and 10 = worst health possible
Timepoint [3] 339511 0
12 weeks post intervention commencement
6 weeks post intervention commencement
Secondary outcome [4] 339512 0
Change in global health of the participants as assessed by the physician using a VAS where 0 = no health problems and 10 = worst health possible
Timepoint [4] 339512 0
12 weeks post intervention commencement, etc.
6 weeks post intervention commencement, etc.
Secondary outcome [5] 339513 0
patient reported number of acute flares over 12 weeks.
Timepoint [5] 339513 0
12 weeks post intervention commencement
6 weeks post intervention commencement
3 weeks post intervention commencement
9 weeks post intervention commencement
16 weeks post intervention commencement
Secondary outcome [6] 339514 0
Change in function as assessed by the Health Assessment Questionnaire ( HAQ)
Timepoint [6] 339514 0
12 weeks post intervention commencement
6 weeks post intervention commencement
Secondary outcome [7] 339515 0
Change in disease activity as assessed by the gout assessment questionnaire ( GAQ )
Timepoint [7] 339515 0
12 weeks post intervention commencement
6 weeks post intervention commencement
Secondary outcome [8] 339516 0
Quality of life (AQoL),
Timepoint [8] 339516 0
12 weeks post intervention commencement
6 weeks post intervention commencement
Secondary outcome [9] 339517 0
safety as determined by patient reported symptoms,
Timepoint [9] 339517 0
3,6,9,12,16 weeks post intervention commencement
Secondary outcome [10] 346386 0
Safety as determined by biochemistry, creatinine, liver function tests, Full blood count, urea and electrolytes at 6 and 12 weeks post treatment commencement
Timepoint [10] 346386 0
6 and 12 weeks post treatment commencement

Eligibility
Key inclusion criteria
1. A diagnosis of gout according to 2015 ACR criteria 21
2. Evidence of inflammation as defined as a CRP>5, or PD signal on US.
3. Able, and willing to commence either krill oil or colchicine.
4. Currently taking, or willing to commence allopurinol therapy.
5. Happy to consent to krill oil therapy for 12 weeks, and review at 12 weeks
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Use of anticoagulants or high dose aspirin (krill oil is contra–indicated in such people).
2. Unwillingness to stop taking krill oil and fish oil medications during the trial.
3. Other forms of inflammatory arthritis (especially rheumatoid arthritis and gout).
4. eGRF <50
5. Moderate to severe hepatic impairment
6. Seafood allergy.
7. Injections of corticosteroids (last 3 months)
8. Pregnancy or breastfeeding.
9. Presence of any serious medical illness that may preclude 12 week follow up.
10. Inability to provide informed consent

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)
central randomization by pharmacy
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated 2:2
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
No pilot data is available to power this study, so a pragmatic decision has been made to include 20 patients in each arm to generate pilot data.
Data will be largely descriptive.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2018
Actual
Date of last participant enrolment
Anticipated
1/11/2018
Actual
Date of last data collection
Anticipated
1/02/2019
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 9162 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [2] 9163 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 17675 0
6150 - Murdoch
Recruitment postcode(s) [2] 17676 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 297695 0
Charities/Societies/Foundations
Name [1] 297695 0
Arthritis Australia
Country [1] 297695 0
Australia
Funding source category [2] 297696 0
Other Collaborative groups
Name [2] 297696 0
Goatcher Clinical Research Unit
Country [2] 297696 0
Australia
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
Murray Street
Perth WA
6000
Country
Australia
Secondary sponsor category [1] 296722 0
None
Name [1] 296722 0
Address [1] 296722 0
Country [1] 296722 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298767 0
Royal Perth Hospital
Ethics committee address [1] 298767 0
Ethics committee country [1] 298767 0
Australia
Date submitted for ethics approval [1] 298767 0
01/08/2017
Approval date [1] 298767 0
20/10/2017
Ethics approval number [1] 298767 0
RGS0000000024

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

Contacts
Principal investigator
Name 78166 0
Dr Helen Keen
Address 78166 0
Perkins South building
Fiona Stanley Hospital,
Murdoch Dive, Murdoch, WA
6150
Country 78166 0
Australia
Phone 78166 0
+ 61 8 61522222
Fax 78166 0
Email 78166 0
[email protected]
Contact person for public queries
Name 78167 0
Helen Keen
Address 78167 0
Perkins South building
Fiona Stanley Hospital,
Murdoch Dive, Murdoch, WA
6150
Country 78167 0
Australia
Phone 78167 0
+61 8 61522222
Fax 78167 0
Email 78167 0
[email protected]
Contact person for scientific queries
Name 78168 0
Kelly Morgan
Address 78168 0
Rheumatology Department,
Royal Perth Hospital
Murray Street
Perth WA
6008
Country 78168 0
Australia
Phone 78168 0
+61 8 92442244
Fax 78168 0
Email 78168 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.