Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000879864
Ethics application status
Approved
Date submitted
16/08/2012
Date registered
20/08/2012
Date last updated
19/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Prevalence of fructose malabsorption in patients with gout.
Scientific title
Prevalence of fructose malabsorption in patients with gout.
Secondary ID [1] 281040 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 287173 0
Intestinal fructose malabsorption

The proposed investigation aims to identify the rates of fructose malabsorption in patients with gout. It is anticipated that this will then lead to further studies of dietary manipulation in patients with and without fructose malabsorption to determine whether dietary fructose restriction results in reduction in serum urate to a greater or lesser extent in each group. 287174 0
Condition category
Condition code
Musculoskeletal 287502 287502 0 0
Other muscular and skeletal disorders
Oral and Gastrointestinal 287503 287503 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
100 patients with gout will be recruited. Patients will be seen on one occasion to undertake a fructose breath test. Patients will be instructed to follow a low-fermentable diet for 24 hours prior to the test. Patients will give a fasting breath test in the morning and then be given a solution of fructose to drink. Repeat breath test will be taken every 15mins for up to 3 hours. The number of additional tests will be determined on case by case basis

Malabsorption of fructose will be defined as breath hydrogen greater than/equal to10ppm above baseline for at least two consecutive 15 minute readings or one reading of greater than 20 ppm above baseline. For those patients who do not produce hydrogen (typically 10-15% of the general population) methane will also be determined and similar cut offs concentrations will be used.

Hydrogen and methane concentrations will be determined using a Quintron microlyser DP. This equipment is a purpose built hydrogen and methane analyser that uses solid state sensors to determine respective gas concentrations. This machine has been used for diagnostic purposes in Christchurch for over three years and is overseen by Scientific Officer Dr Bruce Dobbs. A/Prof Gearry has five years experience in overseeing, interpreting and reporting hydrogen and methane breath tests.
Intervention code [1] 285499 0
Early detection / Screening
Intervention code [2] 285505 0
Lifestyle
Comparator / control treatment
100 controls without gout will be recruited. Cases and controls will be matched on age +/- 10years, gender, and ethnicity. Controls will have the same exclusion criteria as cases. Controls will also undergo the breath test
Control group
Active

Outcomes
Primary outcome [1] 287755 0
To determine whether patients with gout have lower rates of fructose malabsorption compared to the general population.
This will be determined using the fructose breath test using a Quintron microlyser DP
Timepoint [1] 287755 0
The breath test will be undertaken once only.
Secondary outcome [1] 327776 0
To determine the effect of fructose malabsorption (assessed by breath test) on serum urate
Timepoint [1] 327776 0
Fructose breath test performed over 180minutes and serum urate measured at time 0, 15, 30, 60, 90, 120, 180 and 240 mins

Eligibility
Key inclusion criteria
1. Male or female aged >/=18 years

2. Patients fulfil the ACR preliminary classification criteria for gout (Wallace et al. 1977)

3. Subjects are willing and able to participate in the study and from whom written informed consent has been obtained.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Known inflammatory bowel disease or irritable bowel syndrome

2. Receiving diuretic or antibiotic therapy

3. Presence of chronic infection or other severe concomitant medical illness or psychiatric disease.

4. Patients with active, concomitant malignancies.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
100 patients with gout (cases) and 100 controls (without gout) will be enrolled. There is no randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/11/2012
Actual
12/12/2012
Date of last participant enrolment
Anticipated
Actual
27/01/2016
Date of last data collection
Anticipated
Actual
27/01/2016
Sample size
Target
200
Accrual to date
Final
200
Recruitment outside Australia
Country [1] 4488 0
New Zealand
State/province [1] 4488 0
Christchurch

Funding & Sponsors
Funding source category [1] 285825 0
University
Name [1] 285825 0
University of Otago
Country [1] 285825 0
New Zealand
Funding source category [2] 294538 0
Charities/Societies/Foundations
Name [2] 294538 0
Lottery Health New Zealand
Country [2] 294538 0
New Zealand
Primary sponsor type
University
Name
University of Otago, Christchurch
Address
POBox 4345 Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 284651 0
None
Name [1] 284651 0
Address [1] 284651 0
Country [1] 284651 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287846 0
New Zealand Health and Disability Ethics Committee
Ethics committee address [1] 287846 0
Ethics committee country [1] 287846 0
New Zealand
Date submitted for ethics approval [1] 287846 0
24/08/2012
Approval date [1] 287846 0
18/09/2012
Ethics approval number [1] 287846 0
12/STH/11

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34583 0
Prof Lisa Stamp
Address 34583 0
Department of Medicine
University of Otago, Christchurch
P.O.Box 4345
Christchurch 8014
Country 34583 0
New Zealand
Phone 34583 0
+6433640953
Fax 34583 0
Email 34583 0
[email protected]
Contact person for public queries
Name 17830 0
Lisa Stamp
Address 17830 0
Department of Medicine
University of Otago, Christchurch
P.O.Box 4345
Christchurch 8014
Country 17830 0
New Zealand
Phone 17830 0
0064 3640953
Fax 17830 0
Email 17830 0
[email protected]
Contact person for scientific queries
Name 8758 0
Lisa Stamp
Address 8758 0
Department of Medicine
University of Otago, Christchurch
P.O.Box 4345
Christchurch 8014
Country 8758 0
New Zealand
Phone 8758 0
0064 3640953
Fax 8758 0
Email 8758 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.