crohn's disease ulcerative colitis Inflammatory bowel diseases
Conditions
Interventions
Study patients will be treated either with intravenous iron or oral iron. The
brandname of the iv iron is dependent on the hospital policy and the doses will
be according to recommended guidelines (
Sponsors
LITWIN
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Established IBD diagnosis (Crohn's disease, ulcerative colitis, IBD-unclassified) - Adults (>=18 years of age) - Any single Hb level between 6,2 - 7,3 mmol/L (females) 6,2 - 8,0 mmol/L (males) - Any single ferritin 5 mg/L and / or fecal calprotectin > 150 within 4 weeks of randomization - Patients on immunosuppressive medication (thiopurine, methotrexate, biologicals, JAK inhibitor) for at least 8 weeks or if prednisone, for at least 2 weeks - Mild to moderate disease according to the treating physician; e/g/ a Physician Global Assessment (PGA) score of 1 or 2 - Documented informed consent
Exclusion criteria
Exclusion criteria: - Anemia due to reasons other than iron deficiency or chronic disease (e.g. hemoglobinopathy). - Severe disease with a PGA of 3 - IBD patients with a location of IBD at other places than ileum and / or colon (according to treating physician) - Earlier significant side effect of oral iron - Earlier significant side effects, including allergic reaction of iv iron (if another trade name of iv iron is given than in history, and the pharmacist also agrees, inclusion is allowed) - Blood transfusion or therapy with oral and/or intravenous iron in the past eight weeks - Folic acid deficiency (=6 months before the inclusion date. - End-stage renal disease (impaired renal function, defined as eGFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Normalization of Hb concentration (> 7.3 mmol/L (females) or > 8.0 mmol/L (males)) from baseline to week 12 in both oral and iv iron supplementation group. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change in Hb from baseline at week 4, 12 and 16 weeks - Ferritine > 100 microg/l at week 4, 12 and 16 - Preference of patient for oral versus iv iron at baseline and at week 16 - Disease-specific Quality of life (IBDQ) and overall/generic Quality of life (EQ-5D-5L) at week 16 in comparison with baseline - Healthcare use (using the iMCQ questionnaire19), at baseline and week 16 - Work productivity (Work Productivity Activity Index, WPAI20) at baseline and week 16 - Therapy adherence with the modified MMAS for patients in the oral iron group at week 4, 8 en 12 and at week 16 if patients still use iron according to the protocol. - Side effects according to MedDRA criteria - Hepcidin - and soluble Transferrin Receptor (sTfR) - fecal calprotectin / CRP ratio For this outcome, blood will be stored at baseline and at week 12 to determine Hepcidine en soluble Transferin Receptor (sTfR) to can analyze potential differences in retrospect (together with the results of ferritine, CRP and fecal calprotectin). - Does response to iron therapy correlate with disease activity? - How often do patients experience hypophosphatemia as a side effect of iron therapy? | — |
Countries
Netherlands
Contacts
Public ContactAE van der Meulen - de Jong
Leids Universitair Medisch Centrum
Outcome results
None listed