Overview

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

Status:
Not yet recruiting
Trial end date:
2026-01-15
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborator:
Ministry of Health, France
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) <12g/dL & Hb>8g/dL

- Well tolerated anemia

- Iron deficiency defined by: serum iron level < 11 µmol/L, ferritinemia < 20µg/L and/or
transferrin saturation index <0.2

Exclusion Criteria:

- Patient not able to sign, mental illness, pregnancy

- Complicated celiac disease: intestinal malignancies

- Severe anemia (Hb <8g/dL) and/or poorly tolerated anemia requiring systematic iron IV
supplementation or blood transfusion

- Serious severe disease having short-term prognostic implication

- Contraindication to intravenous iron infusion: known drug allergy

- Pregnant or breastfeeding women

- Participation in another interventional trial

- Patients treated by steroids, immunosuppressors or chemotherapy drugs