Predicting Response to Iron Supplementation in Patients With Inflammatory Bowel Disease During Induction Therapy

• Status: Not yet recruiting
• Trial end date: 2023-08-31
• Target enrollment: 0
• Participant gender: All

Summary

Iron deficiency anemia is the most common systemic manifestation of Inflammatory Bowel Diseases (IBD)-Crohn's disease and ulcerative colitis. Iron deficiency with or without anemia poses a diagnostic and therapeutic challenge due to chronic gastrointestinal blood loss and the inflammatory nature of IBD. Recent illumination of iron metabolism has brought attention to the systemic iron regulator-hepcidin, a peptide hormone that regulates intestinal iron absorption and systemic iron availability. Elevated hepcidin is associated with oral iron malabsorption in IBD. This study aims to evaluate whether hepcidin concentration at baseline can predict response to oral and intravenous iron therapy in patients with IBD and concomitant iron deficiency with or without anemia.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Leiden University Medical Center
• Collaborators: Maastricht University Medical Center; Radboud University Medical Center; University Medical Center Groningen
• Treatments: Ferric maltol; Ferrous fumarate; Iron

Criteria

Inclusion Criteria:

• Established IBD diagnosis (Crohn's disease, ulcerative colitis, IBD-unclassified)

• Adults (≥18 years of age)

• Scheduled induction therapy (any induction therapy; e.g., infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, tofacitinib, filgotinib, tacrolimus, etc.)

• 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)

• Proton-pump inhibitor use