drugset / Trial / NCT05456932

Predicting Response to Iron Supplementation in Patients With Active Inflammatory Bowel Disease

NCT05456932

RandomizedParallel-groupOpen-labelDiagnostic

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.

Timeline

Start
2022-08-19
Primary completion
2023-08-31
Completion
2023-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Ferric maltol Small molecule 30 mg Oral
Subject Ferrous Sulfate Diagnostic / imaging agent 100 mg Oral