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Celiac DiseasePhase 4IRONCELNCT05114278

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

A Phase 4 study testing Ferinject and oral iron in people with Celiac Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Celiac Disease
What is being tested?
Ferinject and oral iron
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteFrance
Study dates
8 Jul 2022to 11 Jul 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hôpital Cochin

    Paris, 75014

Other trials in France

About this study

Official title: Effect of Intravenous Iron Supplementation on Celiac Disease Remission in Patients With Iron Deficiency and Intestinal Villous Atrophy: a Randomized Trial

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.

Read the detailed description

Celiac disease is an autoimmune-like disorder induced in genetically predisposed individuals by dietary proteins from wheat (gluten). Its frequency reaches 1% in Europe.

In celiac patients, gluten induces small intestinal villous atrophy and, as a consequence, malnutrition. Celiac disease treatment relies on a long-life strict gluten-free diet that allows clinical and histological recovery and prevents long-term complications (autoimmune diseases, osteoporosis and malignancies). Remission is attested by total villous recovery on duodenal biopsy performed after one year of gluten free diet. Yet, in adults, systematic follow-up of biopsies for several years after gluten free diet initiation has recently revealed persistent villous atrophy in more than 40 % of cases with an increased risk in older patients (up to 56%). Lack of mucosal healing has been associated with the risk of complications in celiac, notably a risk factor for fractures and lymphoma. It is therefore necessary to define strategies to obtain and accelerate full recovery. Iron deficiency is strongly associated with celiac disease and is generally viewed as a consequence of small intestinal lesions and a symptom of malnutrition. Our preliminary clinical retrospective study showed more frequent iron deficiency anemia in celiac patients with (20/70; 29%) than without (11/88; 12.5%) villous atrophy (p = 0.015; OR: 2.78). Our previous experimental study suggests that iron deficiency may sustain tissue damage and delay mucosal recovery in celiac disease. Indeed the transferrin receptor (CD71) is overexpressed in the gut epithelium in case of iron deficiency and can interact with secretory IgA1 present in large amounts in the intestinal lumen of CD patients. Crosslinking of CD71 by polymeric IgA1 can induce production of inflammatory cytokines. Our working hypothesis is therefore that iron deficiency maintains aberrant expression of CD71 at the gut epithelial surface that sustains intestinal inflammation and epithelial damage. Iron supplementation of celiac patients with villous atrophy and iron deficiency may accelerate mucosal healing, villous recovery and remission.

Conditions
Celiac Disease
Being tested
Ferinject, oral iron
Keywords
Celiac disease, Iron deficiency
Medical subject headings
Celiac Disease, Iron Deficiencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FerinjectDrug

    Also called Experimental arm

    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).

  • oral ironDrug

    Also called Control arm

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

Study groups in NCT05114278
Study groupRoleWhat they receive
Oral Iron + IV FerinjectExperimentalExperimental 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.
Receives: Drug: Ferinject; Drug: oral iron
Oral Iron onlyActive comparatorComparison group will not receive any intravenous treatment. Both experimental and comparison groups will receive an oral iron supplementation (100 mg/day).
Receives: Drug: oral iron

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (16)

  1. Atrophic gastritis

    Proportion of patients with atrophic gastritis at V0 and at V14 biopsies (2 in the antrum, 1 in the angulus and 2 in the fundus)

    Measured: 12 months

  2. Partial recovery of intestinal villous atrophy

    Proportion of patients with partial recovery of intestinal villous atrophy on the last control duodenal biopsies according to Marsh classification (centralized histological analysis). Six formalin and two frozen duodenal biopsies will be performed.

    Measured: 12 months

  3. Iron deficiency

    Proportion of patients correcting iron deficiency. Iron parameters (serum iron level (µmol/L), ferritinemia (µg/L), transferrin saturation index) will be assessed at visit V1, V3, V6, V10, V14; correction of iron deficiency is defined by serum iron level > 20 µg/L and transferrin saturation index ≥0.20.

    Measured: 12 months

  4. Anaemia

    Proportion of patients correcting anaemia during the 12 months participation. Hemoglobin (Hb) level (g/d) will be measured at visit V1, V3, V6, V10, V14. Correction of anaemia is defined by Hb≥12g/L in woman and Hb≥13g/dL in man.

    Measured: 12 months

  5. Intraepithelial lymphocytes

    Evolution of the count of intraepithelial lymphocytes assessed on initial and last control biopsy.

    Measured: 12 months

  6. CD71 on epithelial cells

    Evolution of the expression of CD71 on epithelial cells studied on initial and last control biopsy

    Measured: 12 months

  7. Body Mass Index

    Evolution of the patient's BMI during his participation at the study.

    Measured: 12 months

  8. Serum folate level

    Serum folate level (µg/L) measured at visit V1, V3, V6, V10, V14.

    Measured: 12 months

  9. Vitamin B12 level

    Level of vitamin B12 (pmol/L) measured at visit V1, V3, V6, V10, V14.

    Measured: 12 months

  10. Calcemia level

    Level of calcemia (mmol/L) measured at visit V1, V3, V6, V10, V14.

    Measured: 12 months

  11. Albuminemia level

    Level of albuminemia (g/L) measured at visit V1, V3, V6, V10, V14.

    Measured: 12 months

  12. Corrected calcemia level

    Level of corrected calcemia (mmol/L) measured at visit V1, V3, V6, V10, V14.

    Measured: 12 months

  13. 25(OH)D3 vitamin level

    Level of 25(OH)D3 vitamin measured at visit V1, V3, V6, V10, V14.

    Measured: 12 months

  14. Liver enzymes

    Evolution of serum levels of liver enzymes (AST, ALT, AP, gGT, Total Bilirubin), glycemia, T4, TSH measured at visit V1, V3, V6, V10, V14.

    Measured: 12 months

  15. Gluten free diet

    Observance of gluten free diet will be assessed by (i) dietitian assessment of gluten free consumption (g/day and proportion of patients in high (0 g/day), medium (0-50 mg/day), low (>50 mg/day) observance), (ii) measurement of serum celiac antibodies (anti-tTG IgA and anti-deamidated gliadin IgG) and (iii) proportion of patients having gluten immunogenic peptides excretion detected in urine at visit V1, V3, V6,V10, V14.

    Measured: 12 months

  16. Patient quality of life

    French Celiac disease questionnaire assessed at V1 and V14 about the evolution of the quality of life for the patient.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2021
  2. Study start8 Jul 2022
  3. Primary completion8 Jul 2022
  4. Study completion11 Jul 2023

Why it stopped: Study suspended due to a new development; the project was no longer feasible.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Phase IV, open, randomized, 2-arms parallel controlled trial with blinded assessment of end-point.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05114278
Sponsor's protocol ID
P170915J
Other IDs
2019-003125-21, PHRCN-17-0647, 2019
Acronym
IRONCEL
Status last verified
Jul 2026
First submitted
9 Sep 2021
Last updated
9 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ferinject and oral iron in people with Celiac Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study suspended due to a new development; the project was no longer feasible.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total villous recovery (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05114278.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.

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