EFFECT OF INTRAVENOUS IRON SUPPLEMENTATION ON CELIAC DISEASE REMISSION IN PATIENTS WITH IRON DEFICIENCY AND INTESTINAL VILLOUS ATROPHY: A RANDOMIZED TRIA

Phase 1

• Conditions: Celiac patients with iron deficiency and intestinal villous atrophy; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2019-003125-21-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-27
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

- Patients free of mental illness, able to sign consent and > 18years
- Celiac disease confirmed by presence of serum celiac antibodies and villous atrophy on intestinal biopsy before starting gluten free diet
- Intestinal villous atrophy on duodenal biopsy (performed within 1 month) showing villous atrophy
- Patient under gluten free diet or starting gluten free diet 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 transferin saturation index = 0.2
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 102
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 102

Exclusion Criteria

- 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
- Pregnant or breastfeeding women
- Participation in another trial
- Patients treated by steroids, immunosuppressors or chemotherapy drugs

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified