Intravenous iron in adults with cystic fibrosis

Details

Therapeutic category
Nutritional-GI
Trial status
closed Participating Centres
Phase
Phase IV

Full title

A pilot trial of intravenous iron for the treatment of iron deficiency in adult patients with cystic fibrosis

Adults with cystic fibrosis often have low iron levels (iron deficiency). This is partly due to poor absorption of iron from the gut, and partly to the trapping of iron within cells of the immune system during periods of infection. Unfortunately, iron tablets are often ineffective in this setting, and may cause significant side effects in patients with cystic fibrosis. In other patient groups, intravenous iron is used routinely to correct iron deficiency. In these patients it has been shown to be safe, and to improve energy levels, exercise tolerance, cognitive function and quality of life, even in the absence of anaemia. Recent research suggests that iron may be particularly beneficial in patients with heart and lung disease. Despite these possible benefits, IV iron is rarely used in patients with CF, due in part to concerns about encouraging the growth of bacterial in the lungs. Iron deficiency therefore often goes untreated. However, since no clinical trials have examined the use of IV iron in CF patients to date, the risks and benefits remain uncertain. We plan to undertake a small pilot study examining the effects of IV iron in 20 adults with CF and low iron levels. We will primarily assess whether intravenous iron is safe and effective at treating iron deficiency in this group, but will also study various other clinical parameters, to guide the design of future larger studies.
Trial Reference Number
110427
Trial type
Non-medication
Intervention
Intravenous Iron
Recruitment target
20
Last edited date
14/08/2018
CF sponsor
University of Oxford
CF sponsor type
Academic

Who can take part?

Age
18+
Top inclusion criteria
  • Age > = 18 years
  • Iron deficiency
Top exclusion criteria
  • Urgent need for iron supplementation (within 6 weeks of trial)
  • Active infection (currently requiring IV antibiotics)
  • Previous intravenous iron supplementation (within last 4 months)

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