In children with inflammatory bowel disease and iron deficiency, does intravenous iron therapy with Ferric Carboxymaltose significantly improve cognitive function, quality of life and iron status.

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This study aims to define the role of iron deficiency and iron deficiency anaemia in Paediatric Inflammatory Bowel Disease. Iron deficiency with or without anaemia is prevalent in inflammatory bowel disease (IBD) and an adverse impact on quality of life and cognitive function. These effects are likely to be equally if not more severe in the paediatric population. Correction of iron deficiency in IBD is difficult because of ongoing losses and because oral iron is poorly tolerated and bioavailability is impaired in states of inflammation. Given this, intravenous iron preparations are increasingly being used to correct iron deficiency. Previous preparations were complicated by a high rate of anaphylaxis and of iron toxicity which limited the doses administered leading to incomplete correction. We aim to show that the treatment of iron deficiency and iron deficiency anaemia in children using a newer, safer compound with no reported anaphylaxis nor iron toxicity, Ferric Carboxymaltose, is safe and effective in children and that treatment to correction of iron deficiency improves quality of life. This compound has been safely and effectively given, in corrective doses to over 10,000 patients aged 14 and above and there is no reason to indicate it is not equally safe and efficacious in younger children. We also aim to demonstrate improvements in cognitive function after correction of iron deficiency and that the administration of ferric carboxymaltose does not significantly increase markers of lipid peroxidation in paediatric inflammatory bowel disease. The patients included in this prospective open study will be children (six and older) treated for Inflammatory Bowel disease at the Royal Children's Hospital in Brisbane, with documented iron deficiency or iron deficiency anaemia (as defined by published guidelines). Baseline records of iron status (Ganzoni formula, FBC, IS) and quality of life will be obtained through blood tests and the IMPACT III QOL questionnaire (previously validated). A cognitive assessment will also be recorded by a qualified psychologist using a WISC-R. Treatment with Ferric Carboxymaltose will be undertaken (dose 15mg/kg body weight up to 500mg as per current hospital infusion guidelines for patients aged 14 and over. Following this, repeat iron status and quality of life information will be obtained at 8 weeks, with a repeat assessment of cognitive function. Primary endpoints will be defined as correction of total iron stores and improvement in cognitive function and QOL measures.

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