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Trial registered on ANZCTR


Registration number
ACTRN12622001073796
Ethics application status
Approved
Date submitted
25/07/2022
Date registered
3/08/2022
Date last updated
3/08/2022
Date data sharing statement initially provided
3/08/2022
Date results information initially provided
3/08/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Feasibility Study: Curcumin; A clinical trial for gout in Samoa
Scientific title
Using the Samoa population, a feasibility study investigating the effect of curcumin on gout symptoms such as serum urate and gout flare
Secondary ID [1] 307593 0
Nil
Universal Trial Number (UTN)
Trial acronym
CGT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 327037 0
Hyperuricaemia 327038 0
Condition category
Condition code
Musculoskeletal 324208 324208 0 0
Other muscular and skeletal disorders
Alternative and Complementary Medicine 324209 324209 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
500mg curcumin capsule administered orally once per day for 3 months. Adherence will be monitored during each visit using pill counts.
Intervention code [1] 324040 0
Treatment: Other
Comparator / control treatment
A placebo capsule is used as a control treatment. Calcium lactate solution is used as a placebo.
Control group
Placebo

Outcomes
Primary outcome [1] 332025 0
Serum urate.
Serum urate was assessed using a peripheral venous blood sample.
Timepoint [1] 332025 0
Baseline, and 1 (primary endpoint), 2, and 3 months post-intervention commencement
Secondary outcome [1] 411933 0
Gout flares. The number of gout flares in month 1, month 2, and month 3 was assessed using the Gout Flare and Pain Questionnaires/Dairy/LOG (Janssen et al.,20119).
Timepoint [1] 411933 0
Baseline, and 1, 2, and 3 months post-intervention commencement
Secondary outcome [2] 412348 0
The number of attacks. The number of attacks in month 1, month 2, and month 3 was assessed using the Gout Flare and Pain Questionnaires/Dairy/LOG (Janssen et al.,20119).
Timepoint [2] 412348 0
Baseline, and 1, 2, and 3 months post-intervention commencement
Secondary outcome [3] 412352 0
Pain severity. Pain severity in month 1, month 2, and month 3 was assessed using the Gout Flare and Pain Questionnaires/Dairy/LOG (Janssen et al.,20119).
Timepoint [3] 412352 0
Baseline, and 1, 2, and 3 months post-intervention commencement
Secondary outcome [4] 412354 0
Patient global assessment. Patient global assessment in month 1, month 2, and month 3 was assessed using the Patient Global Assessment Questionnaire (Singh et al., 2011).
Timepoint [4] 412354 0
Baseline, and 1, 2, and 3 months post-intervention commencement
Secondary outcome [5] 412356 0
Acceptability of patients to participate. This outcome was assessed using the Feasibility issues questionnaire. This questionnaire was designed specifically for this study.
Timepoint [5] 412356 0
Acceptability of patients to participate will be assessed prior to the commencement of the intervention (Baseline).
Secondary outcome [6] 412357 0
Acceptability of patients to donate their body samples. This outcome was assessed using the Feasibility issues questionnaire. This questionnaire was designed specifically for this study.
Timepoint [6] 412357 0
Patients' acceptability to donate their body samples will be assessed prior to the commencement of the intervention (Baseline).
Secondary outcome [7] 412358 0
Recruitment process. The recruitment process will be assessed by the number of eligible participants enrolled, This outcome was assessed using an audit of the study database.
Timepoint [7] 412358 0
Upon completion of the recruitment process

Eligibility
Key inclusion criteria
• Existing serum urate of greater than or equal to 0.36 mmol/L
• At least 1 gout flare in the last 6 months
• Capable of providing informed consent and having provided it
• Aged between 17 and 80 years
• Gout, according to the 2015 ACR/EULAR classification criteria
• Samoan ethnicity
Minimum age
17 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Severe health issues with poor prognosis (e.g. people on dialysis)
• Severe renal impairment eGFR < 30ml/minutes
• Renal transplant
• Cancer
• Plans to move out of the area within the next 3 months
• Diagnosis with other inflammatory arthritis
• Current consumer of turmeric products

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)
Randomization records of the intervention were stored in a concealment of allocation web-based system (https://www.sealedenvelope.com/) until the analysis starts.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A web-based randomization platform (https://www.randomizer.at/) was used to generate the allocation sequence.
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
This is a feasibility study, hence, 60 patients were randomized into 2 groups of 30 (1:1). Data were analyzed using R software version 4.2.0. All outcomes have been reported as number (n), n percentage, mean ± standard deviation (SD), median, first quartile, and third quartile. Some outcomes are reported with a dot plot to display the count of scores. Differences from baseline to follow-up were reported for both groups for the outcomes included. Inferential analyses were completed, however, they should be interpreted with caution considering this was a feasibility study. Completeness of data was also performed to display the characteristics of patients still in follow-up visits. All the analyses utilized an intention-to-treat approach.
Linear regression analyses were utilized for finding an association of urate with the intervention group, using data from the baseline visit and the month 1 visit. The linear regression model design was that the month-1 serum urate as the outcome and the treatment allocation as an indicator variable and baseline serum urate used as a covariate. The linear regression model calculates the estimated coefficient the estimated confidence interval and the P-value. A P-value < 0.05 was considered significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
6/12/2021
Date of last participant enrolment
Anticipated
Actual
3/01/2022
Date of last data collection
Anticipated
Actual
3/04/2022
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 24898 0
Samoa
State/province [1] 24898 0
Apia

Funding & Sponsors
Funding source category [1] 311861 0
University
Name [1] 311861 0
University of Otago
Country [1] 311861 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
362 Leith Street, Dunedin North, Dunedin 9016, New Zealand
Country
New Zealand
Secondary sponsor category [1] 313338 0
University
Name [1] 313338 0
The National University of Samoa
Address [1] 313338 0
PO Box 1622, To'omatagi, Apia, Upolu, Samoa, Papaigalagala
Country [1] 313338 0
Samoa

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311300 0
University of Otago Human Health Ethics Committee
Ethics committee address [1] 311300 0
1st Floor, Scott/Shand House, 90 St David's Street, Dunedin North, Dunedin 9016, New Zealand
Ethics committee country [1] 311300 0
New Zealand
Date submitted for ethics approval [1] 311300 0
10/02/2021
Approval date [1] 311300 0
01/03/2021
Ethics approval number [1] 311300 0
H21/006
Ethics committee name [2] 311302 0
Samoa Ministry of Health, Health Research Committee
Ethics committee address [2] 311302 0
563P+RP4, Apia, Moto'otua, Samoa
Ethics committee country [2] 311302 0
Samoa
Date submitted for ethics approval [2] 311302 0
03/05/2021
Approval date [2] 311302 0
09/06/2021
Ethics approval number [2] 311302 0

Summary
Brief summary
The study is a feasibility study on the efficacy of curcumin on gout symptoms (i.e., serum urate and gout flare occurrence). This feasibility study addresses issues identified to be potential factors that could affect the future study.
It is hypothesized that curcumin will reduce serum urate levels and reduce the frequency of gout flares in gout patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120626 0
Prof Tony Merriman
Address 120626 0
Biochemistry Department, 710 Cumberland Street, Dunedin North, Dunedin 9016, New Zealand
Country 120626 0
New Zealand
Phone 120626 0
+64 27 234 3905
Fax 120626 0
Email 120626 0
[email protected]
Contact person for public queries
Name 120627 0
Keresoma Leaupepe
Address 120627 0
The National University of Samoa, School of Medicine, Falelauniu WS1361, Apia, Samoa
Country 120627 0
Samoa
Phone 120627 0
+685 7169193
Fax 120627 0
Email 120627 0
[email protected]
Contact person for scientific queries
Name 120628 0
Keresoma Leaupepe
Address 120628 0
The National University of Samoa, School of Medicine, Falelauniu WS1361, Apia, Samoa
Country 120628 0
Samoa
Phone 120628 0
+685 7169193
Fax 120628 0
Email 120628 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
The collective result of patients will be available for sharing.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16657Ethical approval    384392-(Uploaded-28-07-2022-12-54-51)-Study-related document.pdf



Results publications and other study-related documents

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