Treatment of Iron Deficiency Anaemia in Inflammatory Bowel Disease With Ferrous Sulphate
Condition: Ulcerative Colitis; Crohn's Disease
MeSH terms: Crohn Disease; Inflammatory Bowel Diseases; Anemia, Iron-Deficiency; Iron Deficiencies
Intervention: Ferrous sulphate
Intervention description: 200mg tablets.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: This was an open label trial
Enrollment: 90.0
Sex: All
Minimum age: 13 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Iron deficiency anaemia is common in inflammatory bowel disease (IBD), affecting at least 20%
      patients at any one time. Hepcidin, a recently described anti-microbial peptide synthesized
      by the liver, is a key regulator of iron homeostasis. It interferes with absorption of iron
      into enterocytes, macrophages and hepatocytes by binding to ferroportin. Hepcidin levels rise
      when total body iron levels rise and protect against iron overload; conversely, in iron
      deficiency, levels are low. Hepcidin levels also rise under the influence of interleukins
      (IL)-6 and -1, a factor likely to contribute to iron deficient erythropoesis in active IBD.
      Whether hepcidin levels predict resistance to oral iron therapy in IBD is unknown, though it
      may impair its immediate oral absorption. Adult IBD patients who are anaemic report quality
      of life and fatigue scores comparable to those seen in malignancy.

      IBD diagnosed in adolescence interferes with growth, education and employment as well as
      psychosocial and sexual development. Not surprisingly, adolescents with IBD have a high
      prevalence of psychological distress, particular depression. Limited historical, and our own
      data suggest that children and adolescents with IBD are more anaemic than adults, and less
      often treated with oral iron. What is not clear is whether the apparent under-utilisation of
      oral iron in paediatric care is because of a perceived lack of benefit or doctors' concerns
      about possible side effects including worsening disease activity.

      To address these questions, the investigators propose a comparative study of 6 weeks of oral
      iron supplementation in adolescents and adults with iron deficiency anaemia in IBD. Patients
      will be given oral iron supplementation. Before and after iron therapy, the investigators
      shall assess haemoglobin concentrations; IBD activity; quality of life (QOL), perceived
      stress, mood and fatigue; iron metabolism, including serum hepcidin.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients with proven iron deficiency anaemia on World Health Organisation (WHO)criteria
        Patients aged 13 - 18 will be considered adolescents, and aged >18 as adults.

        Exclusion Criteria:

        Anaemia caused by B12 or folate deficiency, or secondary to drugs used to treat IBD;
        haemoglobinopathies or myelodysplasia; severe cardiopulmonary, hepatic or renal disease;
        severe cardiopulmonary, hepatic or renal disease; pregnancy and breast feeding females.