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

NCT05114278 | Terminated Phase 4

• 3 other identifiers: P170915J2019-003125-21PHRCN-17-0647
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Celiac Disease

Keywords

Celiac disease; Iron deficiency

Outcome Measures

Primary Outcomes (1)

• Total villous recovery

  The primary endpoint is the proportion of patients with total villous recovery (total remission) on the last duodenal biopsies. 6 formalin and 2 frozen duodenal biopsies will be performed. Intestinal mucosal assessment will be performed by a centralized histological analysis according to the Marsh classification. Readers will be blind to the treatment received.

  12 months

Secondary Outcomes (16)

• Atrophic gastritis

  12 months

• Partial recovery of intestinal villous atrophy

  12 months

• Iron deficiency

  12 months

• Anaemia

  12 months

• Intraepithelial lymphocytes

  12 months

Study Arms (2)

Oral Iron + IV Ferinject

EXPERIMENTAL

Experimental group will receive intravenous iron infusion (Ferinject©: 15 mg/kg in NaCl solution IV) at randomization, 2weeks after randomization, 4weeks after randomization, and then every month for a total of one year.

Drug: Ferinject; Drug: oral iron

Oral Iron only

ACTIVE COMPARATOR

Comparison group will not receive any intravenous treatment. Both experimental and comparison groups will receive an oral iron supplementation (100 mg/day).

Drug: oral iron

Interventions

Ferinject DRUG

Experimental group will receive intravenous iron infusion (Ferinject©: 15 mg/kg in NaCl solution IV) at randomization, 2weeks after randomization, 4weeks after randomization, and then every month for a total of one year. Comparison group will not receive any intravenous treatment. Both experimental and comparison groups will receive an oral iron supplementation (100 mg/day).

Also known as: Experimental arm

Oral Iron + IV Ferinject

oral iron DRUG

All patients will receive an oral iron supplementation (100mg/day).

Also known as: Control arm

Oral Iron + IV Ferinject; Oral Iron only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Ministry of Health, France: collaborator

Study Sites (1)

Hôpital Cochin

Paris, 75014, France

Location

MeSH Terms

Conditions

Celiac Disease; Iron Deficiencies

Interventions

ferric carboxymaltose; Iron

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Iron Metabolism Disorders

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Georgia MALAMUT, MD, PhD

  Cochin, AP-HP, Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Upper endoscopy with duodenal biopsy will be performed at most one month before randomization, and one month after the last infusion (experimental group) and between the 12th and the 13h month after randomization (control group). Histological analysis (villous recovery, primary endpoint) will be centrally performed by an expert pathologist blind to the group of treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase IV, open, randomized, 2-arms parallel controlled trial with blinded assessment of end-point.

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: November 9, 2021
• Study Start: July 8, 2022
• Primary Completion: July 8, 2022
• Study Completion: July 11, 2023
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Two years after the last publication
• Access Criteria: Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. Data sharing must respect the agreements made with funders. Teams wishing obtain IPD must meet the sponsor and PI team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractual agreement. Processing of shared data must comply with European General Data Protection Regulation (GDPR).

Locations

FR (1)