drugset / Trial / NCT05114278
Effect of Intravenous Iron Supplementation on Celiac Disease Remission (IRONCEL)
Phase 4
Terminated
1 enrolled
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ferric carboxymaltose | Other / unclassified | 15 mg/kg | Intravenous |
| Background | Ferrous Sulfate | Diagnostic / imaging agent | 100 mg | Oral |