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

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Phase: PHASE4

Enrollment: 1

Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Eligibility Criteria

Inclusion Criteria: * Patients free of mental illness, able to sign consent and \>18year * Celiac disease confirmed by presence of serum celiac antibodies and villous atrophy on intestinal biopsy before starting gluten free diet (GFD) * Intestinal villous atrophy on duodenal biopsy (performed within 1 month) showing villous atrophy * Patient under GFD or starting GFD with strict compliance * Hemoglobin level (Hb) \8g/dL * Well tolerated anemia * Iron deficiency defined by: serum iron level \< 11 µmol/L, ferritinemia \< 20µg/L and/or transferrin saturation index \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05114278). StuddyBuddy aggregates publicly available trial information.