EudraCT Number: 2008‐004277‐17.

Trial name or title	The effectiveness and tolerability of GlobiFer (haem iron) tablets compared to ferrous sulphate tablets in inflammatory bowel disease: a randomised‐controlled trial
Methods	A phase 2, multicentre RCT
Participants	Adolescents and adults (> 12years) with established inactive IBD (defined by CDAI < 150 with normal CRP or SCCAI < 4 for patients with Crohn's colitis or colitis and terminal ileal disease and ulcerative colitis respectively) and iron deficiency anaemia (haemoglobin levels at least 1 g/dL below the sex‐specific lowest value [13 g/dL for men and 12 g/dL for women] and either mean cell volume ≤ 80 fl or ferritin ≤100 g/L or transferrin saturation < 20%)
Interventions	Experimental: Oral GlobiFer Forte (iron‐integrated haemoglobin powder equal to 18 mg Fe++) Active comparator: Oral ferrous sulphate 65 mg iron ++ per tablet
Outcomes	Primary outcome: 1 g/dL increase in haemoglobin over baseline at 12 weeks Secondary outcomes: Clinical assessment at each visit: FBC, serum ferritin, transferrin saturation, CRP, ESR, disease activity (CDAI or SCCAI); quality of life (IBDQ); fatigue (10‐point visual analogue scale); analysis of faecal microbiota at baseline, week 12, week 24; safety of treatment ‐ symptoms and side effects (weekly diary card); adverse and serious adverse events
Starting date	Starting date not reported
Contact information	Globifer International bvba, Belgium
Notes	No published data identified in latest search The study was initiated but never completed as there were not enough participants. Findings from the data retrieved were not published, however, a small internal report was completed. 21 participants were enrolled (11 with GlobiFer Forte, 10 with ferrous sulphate) and the conclusion was that GlobiFer Forte seemed to be better tolerated than ferrous sulphate. But it was a small number of participants and a non‐homogeneous data situation so difficult to make a strong conclusion (personal correspondence with Globifer International bvba).