EudraCT Number: 2011‐002122‐43.

Trial name or title	Iron therapy in IBD patients with normal levels of haemoglobin and chronic fatigue
Methods	A multicentre, randomised, placebo‐controlled, double‐blinded trial
Participants	Adults (aged > 18 years) with IBD and chronic fatigue (MFI‐20 > 13). At least 12‐month history of IBD. Inactive Crohn's disease or ulcerative colitis (HBI: < 5, Mayo clinical score: ≤ 2) for at least 6 months. Concurrent stable doses of 5‐aminosalicylate, azathioprine, methotrexate or anti‐tumour necrosis factor alpha. Iron deficiency (ferritin < 100 ng/mL or ferritin 100‐300 ng/mL when transferring saturation < 20%)
Interventions	Experimental: Ferric carboxymaltose 50 mg/mL Comparator: Placebo
Outcomes	Primary outcome: chronic fatigue remission at week 24 (MFI‐20 < 13) Secondary outcomes: clinical response at week 24, defined as decrease in MFI‐20 of at least 4 points, but with a score > 13
Starting date	Not reported
Contact information	Instituto Clinico Humanitas, via Manzoni 56, Rozzano, Italy, 20089 Telephone number: 02 82244033 Fax number: 02 82247208 Email: francesco.minuti@humanitas.it
Notes	No published data identified in latest search Study is still ongoing ‐ personal correspondence with Francesco Minuti (July 2018) Estimated enrollment: 60 participants