Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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
ACTRN12605000426684
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
16/09/2005
Date last updated
16/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prevalence and predictors of malnutrition and decreased bone density in cystic fibrosis
Scientific title
Prevalence and predictors of malnutrition and decreased bone density in cystic fibrosis
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic fibrosis 535 0
Condition category
Condition code
Human Genetics and Inherited Disorders 615 615 0 0
Cystic fibrosis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Questionnaire, genotype, DEXA scan for bone density.
Intervention code [1] 529 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 719 0
Bone mineral density
Timepoint [1] 719 0
Secondary outcome [1] 1481 0
n/a
Timepoint [1] 1481 0

Eligibility
Key inclusion criteria
All adults wwth cystic fibrosis.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/01/2001
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 673 0
University
Name [1] 673 0
Monash Small Project Grants
Country [1] 673 0
Australia
Primary sponsor type
University
Name
Monash Small Project Grants
Address
Country
Australia
Secondary sponsor category [1] 562 0
None
Name [1] 562 0
n/a
Address [1] 562 0
Country [1] 562 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35494 0
Address 35494 0
Country 35494 0
Phone 35494 0
Fax 35494 0
Email 35494 0
Contact person for public queries
Name 9718 0
Associate Professor John Wilson
Address 9718 0
Cystic Fibrosis Service
The Alfred Hospital
Prahran VIC 3181
Country 9718 0
Australia
Phone 9718 0
+61 3 92763601
Fax 9718 0
+61 3 92071050
Email 9718 0
[email protected]
Contact person for scientific queries
Name 646 0
Associate Professor John Wilson
Address 646 0
Cystic Fibrosis Service
The Alfred Hospital
Prahran VIC 3181
Country 646 0
Australia
Phone 646 0
+61 3 92763601
Fax 646 0
+61 3 92071050
Email 646 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.