Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000626662
Ethics application status
Approved
Date submitted
7/10/2005
Date registered
11/10/2005
Date last updated
11/10/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
Cranberry capsules for the prevention of urinary tract infection in an elderly population
Scientific title
A randomised, double-blind, placebo-controlled crossover trial of cranberry capsules to prevent urinary tract infection in an elderly population
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary tract infections 754 0
Condition category
Condition code
Renal and Urogenital 830 830 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The cranberry trial is a randomised double-blind, placebo controlled crossover trial. The study is investigating the efficacy of cranberry capsules for the treatment of urinary tract infections in the elderly. In this trial, clients are randomised to take one capsule, once daily containing either cranberry or a placebo. The trial has a crossover design, with the placebo and intervention each being administered for 3 months duration.
Intervention code [1] 701 0
Prevention
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 1062 0
The incidence of urinary tract infections in elderly clients.
Timepoint [1] 1062 0
Measured monthly via pathology results.
Secondary outcome [1] 1978 0
To determine the effectiveness of urine clarity tests for diagnostic use in an elderly population.
Timepoint [1] 1978 0
Outcome measures are collected weekly.
Secondary outcome [2] 1979 0
To examine the extent to which agitation in clients is associated with urinary tract infection.
Timepoint [2] 1979 0
Outcome measures are collected weekly.

Eligibility
Key inclusion criteria
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

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)
The pharmacy will package and distribute both the cranberry capsule and placebo using a coded number on identical bottles. The researchers and care staff will not be aware of the allocation of capsules.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random numbers will be used and one allocated to each participant. The participant pool will be sorted from highest to lowest, and then split at the median into two groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 918 0
Commercial sector/Industry
Name [1] 918 0
Mayne Consumer Pty Ltd
Country [1] 918 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Blue Care Research Unit
Address
Country
Australia
Secondary sponsor category [1] 776 0
None
Name [1] 776 0
N/A
Address [1] 776 0
Country [1] 776 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2206 0
Blue Care Residential Aged Care Facilities
Ethics committee address [1] 2206 0
Ethics committee country [1] 2206 0
Australia
Date submitted for ethics approval [1] 2206 0
Approval date [1] 2206 0
Ethics approval number [1] 2206 0

Summary
Brief summary
This project seeks to provide evidence for managing urinary tract infection (UTI) using cranberry for an elderly population. Such evidence is important because UTI causes pain and negatively impacts on the quality of life of elderly residents. While there is a growing literature on the use of cranberry for the prevention of UTI, this evidence needs to be further explored within an elderly population specifically. This study will determine if cranberry capsules have an effect on UTI incidence and which particular symptoms and characteristics of bacteriuria it has the greatest effect on.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35610 0
Address 35610 0
Country 35610 0
Phone 35610 0
Fax 35610 0
Email 35610 0
Contact person for public queries
Name 9890 0
Ms Stacey Hassall
Address 9890 0
Blue Care Research Unit
PO Box 1539
Milton BC QLD 4064
Country 9890 0
Australia
Phone 9890 0
+61 7 33773346
Fax 9890 0
+61 7 33773377
Email 9890 0
[email protected]
Contact person for scientific queries
Name 818 0
Ms Stacey Hassall
Address 818 0
Blue Care Research Unit
PO Box 1539
Milton BC QLD 4064
Country 818 0
Australia
Phone 818 0
+61 7 33773346
Fax 818 0
+61 7 33773377
Email 818 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
EmbaseCranberries for preventing urinary tract infections.2023https://dx.doi.org/10.1002/14651858.CD001321.pub7
N.B. These documents automatically identified may not have been verified by the study sponsor.