TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH IBD.

• Research type

  Research Study

• Full title

  TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH INFLAMMATORY BOWEL DISEASE USING FERROUS SULPHATE: TOLERANCE AND EFFECTS ON HAEMOGLOBIN, DISEASE ACTIVITY, MOOD AND QUALITY OF LIFE. AN OPEN LABEL PHASE IV NON-INFERIORITY STUDY.

• IRAS ID

  40738

• Sponsor organisation

  Barts Health Research and Development

• Eudract number

  2010-023797-39

• ISRCTN Number

  n/a

• Research summary

  Iron deficiency anaemia (IDA), largely as a consequence of intestinal blood loss, is common in inflammatory bowel disease (IBD). IBD in young people is increasing, and their disease tends to be more extensive and severe than in adults. It is not surprising therefore that IDA seems to be commoner in young people than adults with IBD. Under-treatment with oral iron tablets may be a contributory factor, possibly due to a perceived lack of benefit of iron supplementation or gastroenterologists?? concerns about possible side effects.IBD in adolescence impairs growth, education, employment and sexual development. Adolescents with IBD suffer more psychological distress than their peers, but whether being anaemic affects mood is unknown. Quality of life (QOL) scores in anaemic adults with IBD resemble those recorded in malignancy. Iron supplementation and correction of anaemia in adults improves QOL, implying that IBD patients when anaemic adapt their behaviour to their symptoms, including a degree of fatigue and reduced exercise tolerance, which may conceivably contribute to a depressed mood. In addition, physiological adaptation to anaemia causes activation of the autonomic nervous system, a state recently implicated in relapse of IBD. We postulate that (1) there is no difference in the response to oral iron treatment of IDA in adolescent compared to adult IBD patients; (2) oral iron does not worsen symptoms or inflammation in IBD; (3) correction of anaemia improves QoL, mood, fatigue, exercise tolerance and disorders of ANS activation associated with IBD.We propose a comparative study of oral iron supplementation in adolescents and adults with IDA in IBD. If they cannot tolerate it orally, patients will be given intravenous iron. Before and after iron therapy, we shall assess haemoglobin concentrations; iron metabolism; IBD activity; QOL, perceived stress, mood, fatigue; exercise tolerance and ANS activation.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  10/H0504/90

• Date of REC Opinion

  11 Jul 2011

• REC opinion

  Further Information Favourable Opinion