Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000479202
Ethics application status
Approved
Date submitted
8/04/2009
Date registered
17/06/2009
Date last updated
19/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized, placebo controlled trial of milk products for prevention of gout flares
Scientific title
A randomized, placebo controlled trial of milk products for prevention of gout flares
Secondary ID [1] 287940 0
NA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 237045 0
Condition category
Condition code
Musculoskeletal 4499 4499 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Daily administration of one of three milk products (two intervention milk products plus one control milk product) for three months. The two intervention products are standard skim milk, and skim milk enriched with milk-derived anti-inflammatory products (Glycomacropeptide [GMP] and G600). Each product will be taken daily as a 250ml drink.
Intervention code [1] 3999 0
Treatment: Other
Intervention code [2] 236768 0
Prevention
Comparator / control treatment
Daily administration of a control milk product (lactose) for three months. This product will be taken daily as a 250ml drink.
Control group
Placebo

Outcomes
Primary outcome [1] 5381 0
Frequency of gout flares (requiring treatment), using a gout flare diary
Timepoint [1] 5381 0
At one, two and three months after the commencement of treatment
Secondary outcome [1] 9046 0
Severity of flare pain (10-point Likert scale)
Timepoint [1] 9046 0
At one, two and three months after the commencement of treatment
Secondary outcome [2] 9047 0
Patient global assessment using a 5-point Likert scale
Timepoint [2] 9047 0
At one, two and three months after the commencement of treatment
Secondary outcome [3] 9048 0
Serum urate concentration (blood test, standard biochemistry assay)
Timepoint [3] 9048 0
At one, two and three months after the commencement of treatment

Eligibility
Key inclusion criteria
1. Diagnosis of gout (based on American College of Rheumatology [ACR]criteria)
2. At least two gout flares in the last four months
3. Able to provide written informed consent
4. Age 18 years and above
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Lactose intolerance
2. Severe renal impairment (glomerular filtration rate [GFR]<30)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Treatment allocations will be randomized by the study statistician, using a variable block size schedule, based on computer-generated random numbers
Masking / blinding
Blinded (masking 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
15/03/2009
Actual
20/07/2009
Date of last participant enrolment
Anticipated
Actual
30/06/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
120
Recruitment outside Australia
Country [1] 1559 0
New Zealand
State/province [1] 1559 0

Funding & Sponsors
Funding source category [1] 4454 0
Other Collaborative groups
Name [1] 4454 0
LactoPharma Consortium
Country [1] 4454 0
New Zealand
Primary sponsor type
Other Collaborative groups
Name
LactoPharma Consortium
Address
L 5 Fonterra Centre, 9 Princes Street.
Private Bag 92032, Auckland
Country
New Zealand
Secondary sponsor category [1] 4013 0
None
Name [1] 4013 0
Address [1] 4013 0
Country [1] 4013 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6809 0
Northern X Regional Ethics Committee
Ethics committee address [1] 6809 0
Ethics committee country [1] 6809 0
New Zealand
Date submitted for ethics approval [1] 6809 0
Approval date [1] 6809 0
28/04/2009
Ethics approval number [1] 6809 0

Summary
Brief summary
This is three-month study of milk products for prevention of gout attacks. Patients with recurrent gout attacks will be randomized to three separate milk powder arms; each product will be administered daily as a 250ml milk drink. The three groups will be a control milk product, a standard skim milk powder, and a skim milk powder enriched with anti-inflammatory factors. We will analyse whether any of the products tested reduces the frequency of gout attacks.
Trial website
Trial related presentations / publications
http://ard.bmj.com/content/71/6/929.long
Public notes

Contacts
Principal investigator
Name 29252 0
Prof Nicola Dalbeth
Address 29252 0
Room 502-201D
Bone and Joint Research Group
Department of Medicine
Faculty of Medical and Health Sciences
University of Auckland
85 Park Rd, Grafton, Auckland 1023
Country 29252 0
New Zealand
Phone 29252 0
+64 (0) 9 3737999 x82568
Fax 29252 0
Email 29252 0
[email protected]
Contact person for public queries
Name 12499 0
Dr Dr Anne Horne
Address 12499 0
Bone Research Group Department of Medicine University of Auckland Park Rd, Grafton, Auckland 1142
Country 12499 0
New Zealand
Phone 12499 0
64 9 307 8970
Fax 12499 0
64 9 373 7677
Email 12499 0
[email protected]
Contact person for scientific queries
Name 3427 0
Prof Nicola Dalbeth
Address 3427 0
Bone Research Group Department of Medicine University of Auckland Park Rd Grafton Auckland 1142
Country 3427 0
New Zealand
Phone 3427 0
64 9 3737999 x 82568
Fax 3427 0
Email 3427 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
EmbaseThe challenges of gout flare reporting: Mapping flares during a randomized controlled trial.2019https://dx.doi.org/10.1186/s41927-019-0075-6
N.B. These documents automatically identified may not have been verified by the study sponsor.