The effect of withdrawal of oral iron supplementation on airway microbiology and outcomes in people with Cystic Fibrosis

• Conditions: Cystic Fibrosis; Respiratory tract infection; Respiratory - Other respiratory disorders / diseases; Human Genetics and Inherited Disorders - Cystic fibrosis; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12612000146897
• Lead Sponsor: Dr Daniel Smith

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

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

Exclusion Criteria

Pregnancy
Current History of Malignancy
Severe Symptomatic anaemia which in the opinion of the treating physicians requires ongoing iron supplementation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Systemic and Sputum Iron Content<br><br>Tools: Blood assessment of total iron, ferritin, soluble transferrin receptors, and transferrin saturations will be measured by ELISA floowing local pathology laboratory standard practices.<br><br>Sputum iron concentration will be measured by Inductively coupled plasma mass spectrometry (ICP-MS)[0, 12, 24, 36, and 52 Weeks]

Secondary Outcome Measures

Name	Time	Method
Sputum Microbiology[0, 12, 24, 36, and 52 Weeks];Exacerbation Frequency<br><br>Tools: Recording of number of courses of antibiotics, total number of days of antibiotic treatment, Number of hopsital admissions[52 Weeks];Daily Symptom Score[0, 12, 24, 36, and 52 Weeks];Lung Function<br><br>Tests used: FEV1, FVC, MMEF[0, 12, 24, 36, and 52 Weeks]