Trial Review

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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 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
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
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
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

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

Documents added automatically
No additional documents have been identified.