Celiac patients with iron deficiency and intestinal villous atrophy
Conditions
Interventions
Trade Name: FERINJECT 50 mg/ml
Pharmaceutical Form: Solution for injection
INN or Proposed INN: FERRIC CARBOXYMALTOSE
CAS Number: 9007-72-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentrat
Sponsors
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Eligibility
Sex/Gender
All
Inclusion criteria
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) 8g/dL - Well tolerated anemia - Iron deficiency defined by: serum iron level =65 years) yes F.1.3.1 Number of subjects for this age range 102
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to assess the efficacy of intravenous iron supplementation on celiac disease remission (total intestinal mucosal recovery). ;Secondary Objective: The second objectives are to assess in patients with celiac disease, iron deficiency and villous atrophy: - the presence of atrophic gastritis on first and control gastric biopsies - the efficacy of intravenous iron supplementation on : o partial intestinal mucosal recovery o correction of iron deficiency o correction of anemia o the number of intestinal intraepithelial lymphocytes o expression of CD71 at the apical site of enterocytes o increase of body mass index o correction of malnutrition o prevention of autoimmune complications o abdominal pain and diarrhea o quality of life - the tolerance of intravenous iron infusion - the compliance to gluten free diet;Primary end point(s): The primary endpoint is the proportion of patients with total villous recovery (total remission) on the last duodenal biopsies. Six formalin and 2 frozen duodenal biopsies will be performed. Intestinal mucosal assessment will be performed by a centralized histological analysis according to Marsh classification. Readers will be blind to the received treatment.;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are: - 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) - 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. - Proportion of patients correcting iron deficiency. Iron parameters (serum iron level (µmol/L), ferritinemia (µg/L), transferin 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 transferin saturation index = 0.20 - Proportion of patients correcting anaemia. 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 - Count of intraepithelial lymphocytes assessed on initial and last control biopsy - Expression of CD71 on epithelial cells studied on initial and last control biopsy - Body Mass Index value assessed at visit V1, V3, V6, V10, and V14 - Proportion of patients recovering normal nutritional parameters. Serum folate level (µg/L), vitamin B12 (pmol/L), calcemia (mmol/L), albuminemia (g/L), corrected calcemia (mmol/L), 25(OH)D3 vitamin mesured at visit V1, V3, V6, V10, V14 - Serum levels of liver enzymes (AST, ALT, AP, gGT, Total Bilirubin), glycemia, T4, TSH measured at visit V1,V3, V6,V10,V14 - Clinical symptoms: diarrhea (daily number of stools), abdominal pain assessed at each visit (n=14) - French Celiac disease questionnaire assessed at V1 and V14 - Proportion of subcutaneous diffusion, allergic reactions, hemodynamic failure evaluated at each visit Observance of gluten free diet will be assessed by dietician assessment of gluten free consumption (g/day), measurement of serum celiac antibodies (anti-tTG IgA and anti-deamidated | — |
Countries
France
Contacts
Public ContactDRCI Hôpital St Louis
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Outcome results
None listed