Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000282583
Ethics application status
Not yet submitted
Date submitted
27/06/2006
Date registered
5/07/2006
Date last updated
5/07/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Dietary advice and management of gout
Scientific title
Dietary advice and gout risk reduction
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 1257 0
Condition category
Condition code
Inflammatory and Immune System 1343 1343 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients with a history of gout will be assessed once only some time between October 2006 and March 2007
Intervention code [1] 1171 0
Prevention
Comparator / control treatment
No comparator.
Control group

Outcomes
Primary outcome [1] 1831 0
Dietary intake using a food frequency questionnaire with specific reference to the previous 12 months.
Timepoint [1] 1831 0
Secondary outcome [1] 3205 0
Risk factor awareness at time of interview.
Timepoint [1] 3205 0
Secondary outcome [2] 3206 0
Dietary modifications since gout diagnosis.
Timepoint [2] 3206 0
Secondary outcome [3] 3207 0
Sources of dietary information since gout diagnosis.
Timepoint [3] 3207 0

Eligibility
Key inclusion criteria
Patients with gout being managed at Repatriation General Hospital, South Australia. Ability to understand and comply with the requirements of the study.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who do not have a history of gout or have gout but are under the age of 18 years. Patients who do not have sufficient oral/written English skills to understand and comply with the requirements of the study.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/09/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1470 0
University
Name [1] 1470 0
Flinders University
Country [1] 1470 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Country
Australia
Secondary sponsor category [1] 1297 0
None
Name [1] 1297 0
None.
Address [1] 1297 0
Country [1] 1297 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 2852 0
Repatriation General Hospital Research and Ethics Committee
Ethics committee address [1] 2852 0
Ethics committee country [1] 2852 0
Australia
Date submitted for ethics approval [1] 2852 0
Approval date [1] 2852 0
Ethics approval number [1] 2852 0

Summary
Brief summary
To determine whether patients with a history of gout are meeting nutritional requirements, are aware of dietary risk factors for their condition and whether they have a need or interest in receiving dietary support for their condition.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35160 0
Address 35160 0
Country 35160 0
Phone 35160 0
Fax 35160 0
Email 35160 0
Contact person for public queries
Name 10360 0
Dr Michelle Miller
Address 10360 0
Department of Nutrition and Dietetics
Block G4, FMC Flats
Flinders Drive, Bedford Park SA 5041
Country 10360 0
Australia
Phone 10360 0
61 8 82045328
Fax 10360 0
61 8 82046406
Email 10360 0
[email protected]
Contact person for scientific queries
Name 1288 0
Dr Michelle Miller
Address 1288 0
Department of Nutrition and Dietetics
Block G4 FMC Flats
Flinders Drive Bedford Park SA 5041
Country 1288 0
Australia
Phone 1288 0
61 8 82045328
Fax 1288 0
61 8 82046406
Email 1288 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.