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

Summary

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).

Conditions

• Celiac Disease in Children
• Anemia
• Iron Deficiencies

Interventions

DIETARY_SUPPLEMENT

Sideral forte® VERUM drops

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.

DIETARY_SUPPLEMENT

Sideral forte® VERUM drops

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.

DIETARY_SUPPLEMENT

Sideral forte® matching PLACEBO drops

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.

DIETARY_SUPPLEMENT

Sideral forte® matching PLACEBO drops

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.

Sponsors & Collaborators

• Pharmanutra S.p.a.

  collaborator INDUSTRY

• Istituto Giannina Gaslini

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

8 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-23

Primary Completion

2027-03-31

Completion

2027-09-30

Countries

• Italy

Study Locations