Efficacy of Oral Sucrosomial Iron Supplementation in Children With Celiac Disease and Iron Deficiency or Anemia

Istituto Giannina Gaslini60 enrolled

Overview

Celiac disease in children is frequently associated with iron deficiency and/or iron deficiency anemia due to intestinal malabsorption and chronic inflammation. Although a gluten-free diet is the standard treatment and can restore iron balance over time, there is currently no clear evidence or consensus on the role and timing of iron supplementation in pediatric patients at diagnosis. Given the potential impact of anemia on growth and neurodevelopment, strategies that enable a faster correction of iron deficiency are clinically relevant. Sucrosomial® iron has shown improved absorption and gastrointestinal tolerability compared to conventional oral iron in adult celiac patients. This study aims to evaluate whether Sucrosomial® iron supplementation, in addition to a gluten-free diet, is more effective and safe than diet alone in achieving a faster normalization of hemoglobin and iron stores in children with newly diagnosed celiac disease. The primary objective of this randomized, double-blind, placebo-controlled, parallel-group study is to assess whether oral supplementation with Sucrosomial® iron, when added to a gluten-free diet (GFD), accelerates the normalization of iron stores and hemoglobin levels compared with GFD alone in school-age children and adolescents newly diagnosed with celiac disease presenting with hypoferritinemia and/or iron deficiency anemia. Target Study Population: Children and adolescents with celiac disease and iron deficiency or anemia due to iron deficiency. Study Duration Total study duration (per patient) will be about 6 months; total treatment duration (per patient) will be 6 months. Number of Patients: 60 planned Two typologies of patients will be included: with hypoferritinemia and with anemia due to iron deficiency. The randomization process will be stratified, so that: * 15 patients with hypoferritinemia receive active treatment and 15 patients receive placebo; * 15 patients with anemia due to iron deficiency receive active treatment and 15 patients receive placebo. The age of patients will also be considered for the randomization (to assign the correct number of product bottles).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Interventions

Sideral forte® VERUM dropsDIETARY_SUPPLEMENT

Patients with hypoferritinemia (no anemia): * From 8 years until development (Tanner stage \<=3): 1 ml of Sideral forte® VERUM drops, equal to 14 mg of iron element; * From development (Tanner stage \>3) up to 18 years: 2 ml of Sideral forte® VERUM drops, equal to 28 mg of iron element.

Sideral forte® VERUM dropsDIETARY_SUPPLEMENT

Patients with anemia due to iron deficiency: * From 8 years until development (Tanner stage \<=3): 2 ml of Sideral forte® VERUM drops, equal to 28 mg of iron element; * From development (Tanner stage \>3) up to 18 years: 3 ml of SiderAL FORTE oral drops, equal to 42 mg of iron element.

Sideral forte® matching PLACEBO dropsDIETARY_SUPPLEMENT

Patients with hypoferritinemia (no anemia): * From 8 years until development (Tanner stage \<=3): 1 ml/day of PLACEBO drops; * From development (Tanner stage \>3) up to 18 years: 2 ml/day of of PLACEBO drops.

Sideral forte® matching PLACEBO dropsDIETARY_SUPPLEMENT

Patients with anemia due to iron deficiency: * From 8 years until development (Tanner stage \<=3): 2 ml of PLACEBO drops; * From development (Tanner stage \>3) up to 18 years: 3 ml of PLACEBO drops.

Eligibility

Sex: ALLMin age: 8 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Diagnosis of CD according to the current European ESPGHAN guidelines (clinical or histological) with confirmed hypoferritinemia or iron deficiency anemia. 2. Age at diagnosis of CD between 8 and 18 years (inclusive). 3. Absence of oral martial supplementation in the 30 days before the diagnosis and intravenous martial supplementation in the 90 days prior to the diagnosis of CD. 4. Patients who have not already started GFD before diagnosis. 5. Exclusion of other causes of anemia. 6. Patients (and parents/legal guardian) able to understand and willing to participate in the study, with collaborative attitude. 7. Informed consent release by both parents/legal guardian. Exclusion Criteria: 1. Potential celiac disease. 2. Hb \< 8 g/dL at screening 3. Other causes of anemia, hemoglobinopathies or coagulopathies. 4. Active bleeding or surgery or major trauma in the last 6 months. 5. Other inflammatory diseases, neoplasms or IgE mediated food allergies 6. Syndromes or presence of vascular malformations 7. Pregnant or lactating patients (based on self-certification by the parents and by the patient, where applicable)\* 8. Patients with known or suspected allergy or hypersensitivity to the study products or any of their excipients. 9. Taking oral iron-based medications in the 30 days prior to diagnosis and intravenous iron-based medications in the 90 days prior to diagnosis. 10. Use of other investigational drug(s) within 30 days before study entry or during the study. 11. Any other condition, illness or treatment that in the Investigator's opinion does not make the patient suitable for the study. * Self-certification of non-pregnancy status is considered sufficient given that the product under study is a safe and well-tolerated dietary supplement that has already been tested in pregnant women.

Outcomes

Primary Outcomes

Time to normalization of iron status

Time from baseline (defined as the time from diagnosis of celiac disease) to the first documented normalization of iron status. Normalization is defined as: * hemoglobin (Hb) within age- and sex-specific reference ranges in participants with iron deficiency anemia at baseline, or * serum ferritin within reference ranges in participants with isolated hypoferritinemia at baseline Comparisons will be performed between participants receiving oral Sucrosomial® iron supplementation plus a gluten-free diet (GFD) and those receiving GFD alone.

Time frame: From enrollment to the end of the treatment at 6 months

Secondary Outcomes

Change in hemoglobin

Change in hemoglobin (Hb) levels (gr/dl) from baseline to 6 months. Comparisons will be performed between participants receiving oral Sucrosomial® iron supplementation plus a gluten-free diet (GFD) and those receiving GFD alone.