Treatment of Iron Deficiency Anaemia in Adults and Adolescents With Inflammatory Bowel Disease Using Ferrous Sulphate: Tolerance and Effects on Haemoglobin, Mood, Quality of Life and Fatigue

Methods Before and after iron therapy, we assessed haemoglobin concentrations; iron status markers; serum hepcidin concentration; IBD activity; iron tolerance; and QOL, perceived stress, mood, coping and fatigue using psychometric questionnaires.

Patients. Patients aged 13 - 18 years were defined as adolescents, and those aged ≥ 19 years as adults. Between January 2012 and April 2015, patients with IBD (ulcerative colitis (UC), Crohn's disease or IBDU (IBD unclassified) diagnosed by standard clinical, radiological and pathological criteria) who within the next month were due to attend the adult, young people's and paediatric IBD clinics at Barts and the Royal London Hospitals, Barts Health Trust or the paediatric IBD clinic at Chelsea and Westminster NHS Trust, London, UK, were screened for the result of their haemoglobin concentration at their previous clinic attendance. Those found to be anaemic were sent a letter of explanation about, and invitation to participate in, the trial. They were telephoned 1-2 weeks after this letter was sent to them and asked about current and previous iron therapy: those apparently eligible (see below) and verbally consenting to participate were then seen by a trial doctor or research nurse either at their next clinic appointment, or on another mutually convenient occasion. Informed written consent from the patients or their parents, as appropriate, was obtained at this meeting, and patients who remained eligible on the basis of their iron therapy history and clinical, and haematological criteria were enrolled in the trial.

Definition of iron deficiency anaemia: Anaemia was defined by age and sex-adjusted World Health Organisation criteria (males <13.0 g/dl; females and children aged 13 years <12.0 g/dl) (WHO 2001). For inclusion in the trial, patients had to be both anaemic and have transferrin saturation <18%. They also had to report either tolerance of previous course(s) of oral iron, or to be naïve to this treatment.

Exclusion criteria: Patients were excluded if they did not meet the haematological inclusion criteria on the admission-to-study blood test ('screening failures'), if they had been given oral or intravenous iron within 3 months, or if they had previously been intolerant of oral iron. Other exclusion criteria were age <13 years, vitamin B12 or folate deficiency, anaemia caused by drugs used to treat IBD, haemoglobinopathy, presence of stoma or ileoanal pouch, severely active IBD requiring hospital admission from clinic, severe cardiopulmonary, hepatic, renal or other disease, pregnancy, breast-feeding, use of cholestyramine, and inability to speak English well enough to complete the consent form or psychometric questionnaires.

Regulatory and funding considerations: The trial was approved by the Southampton National Research Ethics Committee (number 10/H504/90 and EUDRACT number 2010-023797-39) and was necessarily registered as a Clinical Trial of an Investigational Medical Product (CTIMP) with the Medicines and Healthcare Products Regulatory Agency (number 14620/0035/001-0001) and ClinTrials.Gov. The trial was sponsored by Barts Health NHS Trust. The trial was kindly funded by a grant from Core and British Society for Paediatric Gastroenterology, Hepatology and Nutrition.