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PTH-066 Clinical Trial: Effects of Oral Ferrous Sulphate on Haemoglobin, Hepcidin, Disease Activity, Mood and Quality of Life in Adolescents and Adults with Iron Deficiency Anaemia Due to IBD
  1. J Goodhand1,
  2. D Rampton1,
  3. N Joshi1,
  4. A-B Karim1,
  5. Y Koodun1,
  6. L Macken1,
  7. F Baraket1,
  8. J Epstein2,
  9. J Fell2,
  10. D Ward3,
  11. T Iqbal3,
  12. I Sanderson1
  1. 1Barts Health NHS Trust
  2. 2Chelsea and Westminster NHS trust, London
  3. 3University of Birmingham, Birmingham, UK

Abstract

Introduction Iron deficiency anaemia (IDA) is common in inflammatory bowel disease (IBD), can be hard to treat and has a negative impact on quality of life (QOL). Because of previous concerns about the efficacy and safety of oral iron, particularly in young people with IBD, we undertook a trial to assess whether ferrous sulphate is as effective and well-tolerated in adolescents as in adults with IBD.

Methods Prospective phase IV, open-label, parallel group, 6 week non-inferiority clinical trial to compare the effects of oral ferrous sulphate 200 mg twice daily on Hb, iron status, serum hepcidin, symptoms, disease activity (Harvey-Bradshaw Index, Simple Colitis Clinical Activity Index, C-reactive protein (CRP), faecal calprotectin (FCP), QOL, mood and fatigue psychometric scores in 43 adolescent (age 13–18 years) and 45 adult (>18 years) IBD patients with IDA who were either oral iron-naïve or previously iron-tolerant.

Results On intention-to treat analysis, ferrous sulphate produced similar small but statistically significant rises in serum Hb in the adolescent (before treatment 10.3 g/dl [0.2] (mean [SEM]); after 11.7 [0.2]: p < 0.0001) and adult groups (before 10.9 g/dl [0.1]; after 11.9 [0.2]: p < 0.0001). There was no statistically significant difference in Hb respone or % transferrin saturation response between the two groups. 24 patients (12 adolescents, 12 adults) failed to complete the protocol, 11 because of iron intolerance. On a per protocol basis, oral iron did not change FCP: adolescents (n = 22) (before 324 ug/g [51], after 281 [47]: p = 0.55); adults (n = 22) (before 359 ug/g [107], after 301 [80]: p = 0.54); CRP was also unaffected by oral iron. There was no relation between baseline FCP and baseline Hb or hepcidin, or the Hb response to oral iron. However, baseline hepcidin was negatively associated with Hb response to oral iron (r = 0.28, p = 0.02). The change in Hb following administration of ferrous sulphate had no effect on the Short IBDQ, Hospital Anxiety and Depression (HADS-A & D), Perceived Stress Questionnaire, or the multi-dimension fatigue inventory (MFI) scores.

Conclusion Oral ferrous sulphate is no less effective or well-tolerated in adolescents than in adults with IBD, and does not increase disease activity. Baseline serum hepcidin level is inversely related to the increase in Hb produced by oral iron in patients with IBD: its measurement could indicate which patients would do better with intravenous than oral iron. Change in Hb had no effect on QoL, mood or fatigue scores.

Disclosure of Interest None Declared

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