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Trial registered on ANZCTR


Registration number
ACTRN12612000146897
Ethics application status
Approved
Date submitted
1/02/2012
Date registered
1/02/2012
Date last updated
1/02/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of withdrawal of oral iron supplementation on airway microbiology and outcomes in people with Cystic Fibrosis
Scientific title
The effect of withdrawal of oral iron supplementation on airway microbiology and outcomes in people with Cystic Fibrosis
Secondary ID [1] 279816 0
None
Universal Trial Number (UTN)
None
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 285700 0
Respiratory tract infection 285728 0
Condition category
Condition code
Respiratory 285883 285883 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 285911 285911 0 0
Cystic fibrosis
Infection 285912 285912 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients currently prescribed oral iron supplementation who are revealed to no longer be iron deficient will have their oral iron supplements stoped, this process may be done without a need to taper.
Intervention code [1] 284136 0
Prevention
Comparator / control treatment
Nil - Patients baseline data prior to withdrawal of iron supplementation will be compared to their longitudinal data following withdrawal of iron supplements
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286379 0
Systemic and Sputum Iron Content

Tools: Blood assessment of total iron, ferritin, soluble transferrin receptors, and transferrin saturations will be measured by ELISA floowing local pathology laboratory standard practices.

Sputum iron concentration will be measured by Inductively coupled plasma mass spectrometry (ICP-MS)
Timepoint [1] 286379 0
0, 12, 24, 36, and 52 Weeks
Secondary outcome [1] 295733 0
Sputum Microbiology
Timepoint [1] 295733 0
0, 12, 24, 36, and 52 Weeks
Secondary outcome [2] 295734 0
Exacerbation Frequency

Tools: Recording of number of courses of antibiotics, total number of days of antibiotic treatment, Number of hopsital admissions
Timepoint [2] 295734 0
52 Weeks
Secondary outcome [3] 295735 0
Daily Symptom Score
Timepoint [3] 295735 0
0, 12, 24, 36, and 52 Weeks
Secondary outcome [4] 295736 0
Lung Function

Tests used: FEV1, FVC, MMEF
Timepoint [4] 295736 0
0, 12, 24, 36, and 52 Weeks

Eligibility
Key inclusion criteria
Diagnosis of Cystic Fibrosis
Aged Greater Than 18 years Old
Competant to give written informed consent
Able to Complete written questionnaires in the English Language
Currently taking oral iron supllementation but with normal iron stores as indicated by a soluble transferrin receptor / Log ferritin ration of less than 1.54
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy
Current History of Malignancy
Severe Symptomatic anaemia which in the opinion of the treating physicians requires ongoing iron supplementation

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be recruited by face to face contact at the time of a hospital outpatient or inpatient consultation.

There is no random allocation of treatment
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
Type of endpoint(s)
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 284597 0
Charities/Societies/Foundations
Name [1] 284597 0
The Prince Charles Hospital Research Foundation
Address [1] 284597 0
The Prince Charles Hospital
Rode Road
Chermside
Brisbane
Queensland
4032
Country [1] 284597 0
Australia
Funding source category [2] 284607 0
Hospital
Name [2] 284607 0
The Royal Hobart Hospital Research Fellowship
Address [2] 284607 0
The Royal Hobart Hospital
48 Liverpool Street
Hobart,
Tasmania
7000
Country [2] 284607 0
Australia
Primary sponsor type
Individual
Name
Dr Daniel Smith
Address
Department of Thoracic Medicine
The Prince Charles Hospital
Rode Road
Chermside
Brisbane
Queensland
4032
Country
Australia
Secondary sponsor category [1] 283514 0
None
Name [1] 283514 0
N/A
Address [1] 283514 0
N/A
Country [1] 283514 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286581 0
The Prince Charles Human Research and Ethics Committee
Ethics committee address [1] 286581 0
The Prince Charles Hospital
Rode Road
Chermside
Brisbane
Queensland
4032
Ethics committee country [1] 286581 0
Australia
Date submitted for ethics approval [1] 286581 0
Approval date [1] 286581 0
03/05/2011
Ethics approval number [1] 286581 0
HREC/11QPCH/36

Summary
Brief summary
The study is an open study examining the effects of withdrawal of oral iron supplements in patients with the genetic condition Cystic Fibrosis (CF). In CF it is believed that unusually high levels of iron can be found in respiratory tract, and that the presence of iron within the airways may promote bacterial infection.

In this study we explore how withdrawal of iron supplements may effect airway iron content and microbiology. As well as assessing the effect on systemic iron stores, lung function, and disease related symptoms.

This study will be conducted by the staff of the Adult Cystic Fibrosis Centre located at The Prince Charles Hospital, Brisbane, Australia.

All patients who meet the inclusion criteria will be invited to participate. Subjects will provide written informed consent prior to participation. If patients decide to withdraw from the study at any point this will not have any impact on their ongoing care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33696 0
Address 33696 0
Country 33696 0
Phone 33696 0
Fax 33696 0
Email 33696 0
Contact person for public queries
Name 16943 0
Dr Daniel Smith
Address 16943 0
Department of Thoracic Medicine
The Prince Charles Hospital
Rode Road
Brisbane
Queensland
4032
Country 16943 0
Australia
Phone 16943 0
+61 7 31394000
Fax 16943 0
+61 7 31395630
Email 16943 0
dnsmith58@aol.com
Contact person for scientific queries
Name 7871 0
Dr Daniel Smith
Address 7871 0
Department of Thoracic Medicine
The Prince Charles Hospital
Rode Road
Brisbane
Queensland
4032
Country 7871 0
Australia
Phone 7871 0
+61 7 31394000
Fax 7871 0
+61 7 31395630
Email 7871 0
dnsmith58@aol.com

No data has been provided for results reporting
Summary results
Not applicable