Oral versus intravenous iron in IBD patients with anti-inflammatory therapy

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 152

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 <100 µg/L and transferrin saturation <20% within 4 weeks
of study inclusion
- CRP > 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

- 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 (<2.5 µg/ml)
- Vitamin B12 deficiency (<150 mg/l)
- Documented history of bariatric surgery or gastric/duodenal resections due to
benign or
malignant pathologies
- Documented history of liver cirrhosis, heart failure, hemoglobinopathies,
autoimmune
hemolytic anemia, myelodysplastic syndrome, or chronic obstructive pulmonary
disease
(COPD)
- Documented history of recent treatment for a malignancy (excluding
dermatological
malignancies such as basal cell carcinoma or squamous cell carcinoma).
Patients can
be included if the treatment for malignancy has been finalized >=6 months
before the
inclusion date.
- End-stage renal disease (impaired renal function, defined as eGFR <30
ml/min/1.73m2)
- Documented pregnancy or breastfeeding at the time of inclusion
- Documented major operation (e.g., laparotomy) less than six weeks before
inclusion
- Unable to give informed consent due to inability to onderstand Dutch language
or incapacitation (e.g., due to cognitive/psychological conditions or
hospitalization in Intensive Care)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Normalization of Hb concentration (> 7.3 mmol/L (females) or > 8.0 mmol/L<br /><br>(males)) from baseline to week 12 in both oral and iv iron supplementation<br /><br>group.</p><br>

Secondary Outcome Measures