drugset / Trial / NCT05114278

Effect of Intravenous Iron Supplementation on Celiac Disease Remission (IRONCEL)

NCT05114278

RandomizedParallel-groupSingle-blindTreatment

Summary

The study aims is to evaluate the efficacy of intravenous iron supplementation on celiac disease remission (total intestinal mucosal recovery). This randomized multicenter trial compare the administration of intravenous iron by infusion (Ferinject©: 15 mg/kg in NaCl solution in 30 min) and oral iron in combination; to patients receive only oral iron as standard care. The first benefit with IV Iron supplementation is to correct iron deficiency more rapidly than oral iron alone because of trouble of absorption in case of intestinal villous atrophy.

Timeline

Start
2022-07-08
Primary completion
2022-07-08
Completion
2023-07-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Ferric carboxymaltose Other / unclassified 15 mg/kg Intravenous
Background Ferrous Sulfate Diagnostic / imaging agent 100 mg Oral

Indications