Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000741583
Ethics application status
Approved
Date submitted
6/07/2015
Date registered
17/07/2015
Date last updated
12/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Tart cherry concentrate in gout: a dose ranging study
Scientific title
Determining the effects of tart cherry concentrate on gout flares and serum urate in patients with gout
Secondary ID [1] 287043 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 295517 0
Condition category
Condition code
Musculoskeletal 295786 295786 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 295843 295843 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive tart cherry concentrate as liquid at one of the following doses for 28 days: 1/2tbsp twice daily, 1 tbsp twice daily, 1.5tbsp twice daily or 2 tbsp twice daily all added in 250mls water and drunk.
Adherence will be measured by self-report, empty bottle return and measurement of anthocyanins in plasma and urine
Intervention code [1] 292260 0
Treatment: Other
Comparator / control treatment
2 drops of tart cherry concentrate as a liquid in 250mls water drunk twice daily
Control group
Dose comparison

Outcomes
Primary outcome [1] 295487 0
The optimal dose of tart cherry concentrate to reduce serum urate
Timepoint [1] 295487 0
28 days
Secondary outcome [1] 315689 0
Patient adherence with tart cherry concentrate as assessed by self-report, empty bottle return and plasma and urine anthocyanin concentrations
Timepoint [1] 315689 0
28 days
Secondary outcome [2] 315690 0
Effect of tart cherry concentrate on gout flares as assessed by self-report flare diary.
Timepoint [2] 315690 0
28 days

Eligibility
Key inclusion criteria
1. Gout as defined by American Rheumatism Association Criteria
2. Serum urate >0.36mmol/l
3. Willing and able to provide informed consent
4. Willing and able to adhere to the study protocol
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Type 1 diabetes
2. Creatinine clearance <50mls/min
3. Diuretic use
4. allergic to cherries or cherry concentrate
5. Other serious medical conditions that preclude involvement

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2016
Actual
29/02/2016
Date of last participant enrolment
Anticipated
18/12/2017
Actual
26/02/2018
Date of last data collection
Anticipated
26/01/2018
Actual
26/03/2018
Sample size
Target
50
Accrual to date
Final
50
Recruitment outside Australia
Country [1] 7020 0
New Zealand
State/province [1] 7020 0
Christchurch

Funding & Sponsors
Funding source category [1] 291598 0
Government body
Name [1] 291598 0
Health Research Council of New Zealand
Country [1] 291598 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
P.O.Box 4345
Christchurch 8014
Country
New Zealand
Secondary sponsor category [1] 290269 0
None
Name [1] 290269 0
Address [1] 290269 0
Country [1] 290269 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293129 0
Northern B Health and Disability Ethics Committee of New Zealand
Ethics committee address [1] 293129 0
C/- MEDSAFE, Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington 6145
Ethics committee country [1] 293129 0
New Zealand
Date submitted for ethics approval [1] 293129 0
20/07/2015
Approval date [1] 293129 0
15/09/2015
Ethics approval number [1] 293129 0
15/NTB/133

Summary
Brief summary
Gout is the most common form of arthritis in men >40 years of age. The primary biochemical abnormality is elevated serum urate (hyperuricaemia). Hyperuricaemia (serum urate >0.42mmol/L) results from either over production or under excretion of urate. When supersaturation levels are reached, uric acid crystals form and deposit in joints and periarticular tissues, where they cause damage through local mechanical pressure and acute/chronic inflammation. Over time, repeated attacks of gout lead to cartilage damage, bone erosion and permanent disability. The aim of gout management is to reduce serum urate levels to <0.36mmol/L. If serum urate concentrations are consistently maintained at or below this level gouty attacks subside and tophi reduce in size and number . Nutritional supplementation with tart cherry concentrate has been suggested based on previous small studies that revealed a reduction in gout flares in patients consuming large amounts of cherries or tart cherry concentrate. These data are limited to observational studies and the only clinical trials are in small numbers of patients. Thus there is a need for prospective clinical trials of the effects of tart cherry concentrate in patients with gout. The aim of this study is to determine the most effective dose of tart cherry concentrate for use in a large clinical trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58606 0
Prof Lisa Stamp
Address 58606 0
Department of Medicine
University of Otago, Christchurch
P.O. Box 4345
Christchurch 8014
Country 58606 0
New Zealand
Phone 58606 0
+64 - 3-364- 0253
Fax 58606 0
Email 58606 0
[email protected]
Contact person for public queries
Name 58607 0
Prof Lisa Stamp
Address 58607 0
Department of Medicine
University of Otago, Christchurch
P.O. Box 4345
Christchurch 8014
Country 58607 0
New Zealand
Phone 58607 0
+64 -3- 364- 0253
Fax 58607 0
Email 58607 0
[email protected]
Contact person for scientific queries
Name 58608 0
Prof Lisa Stamp
Address 58608 0
Department of Medicine
University of Otago, Christchurch
P.O. Box 4345
Christchurch 8014
Country 58608 0
New Zealand
Phone 58608 0
+64 -3- 364- 0253
Fax 58608 0
Email 58608 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
SourceTitleYear of PublicationDOI
EmbaseLack of effect of tart cherry concentrate dose on serum urate in people with gout.2020https://dx.doi.org/10.1093/rheumatology/kez606
N.B. These documents automatically identified may not have been verified by the study sponsor.