Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-24 @ 9:48 PM
NCT ID:
NCT05456932
Eligibility Criteria:
Inclusion Criteria:
* Established IBD diagnosis (Crohn's disease, ulcerative colitis, IBD-unclassified)
* Adults (≥18 years of age)
* Active IBD (defined as any endoscopic, radiologic or biochemical disease activity \[fecal calprotectin \>150 mg/kg or C-reactive protein \>5 mg/l\])
* Iron deficiency anemia (defined as ferritin \<100 ug/l and hemoglobin \<7.5 mmol/l for females or \<8.5 mmol/l for males) or iron deficiency (defined as ferritin \<100 ug/l and transferrin saturation \<20%)
* Documented informed consent
Exclusion Criteria:
* Blood transfusion or therapy with oral and/or intravenous iron in the past eight weeks
* Documented intolerance to oral or intravenous iron
* Severe anemia (defined as hemoglobin \<6.2 mmol/l for females and males)
* Documented history of liver cirrhosis, heart failure, hemoglobinopathies, autoimmune hemolytic anemia, myelodysplastic syndrome, or chronic obstructive pulmonary disease
* 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.
* Documented history of bariatric surgery or gastric/duodenal resections due to benign or malignant pathologies
* End-stage renal disease (impaired renal function, defined as estimated Glomerular Filtration Rate (eGFR) \<30 ml/min/1.73m2)
* Folic acid deficiency
* Vitamin B12 deficiency
* 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 understand Dutch language or incapacitation (e.g., due to cognitive/psychological conditions or hospitalization in Intensive Care)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05456932
Study Brief:
Protocol Section:
NCT05456932