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

NCT07563582 | Recruiting

• 1 other identifier: CD-GAS-FESUCR
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Iron deficiency/anemia due to iron deficiency in CD children and adolescents

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of the treatment at 6 months

Secondary Outcomes (16)

• Change in hemoglobin

  Baseline to 6 months

• Change in serum ferritin

  Baseline to 6 months

• Change in mean corpuscular volume (MCV)

  Baseline to 6 months

• Change in mean corpuscular hemoglobin (MCH)

  Baseline to 6 months

• Change in mean corpuscular hemoglobin concentration (MCHC)

  Baseline to 6 months

Other Outcomes (1)

• Changes from baseline in inflammatory biomarkers

  From enrollment to the end of the treatment at 6 months

Study Arms (2)

Sideral forte® VERUM drops for oral intake in addition to GFD

EXPERIMENTAL

Dietary Supplement: Sideral forte® VERUM drops

Sideral forte® matching PLACEBO drops for oral intake in addition to GFD

PLACEBO COMPARATOR

Dietary Supplement: Sideral forte® matching PLACEBO drops

Interventions

Sideral forte® VERUM drops DIETARY_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 drops for oral intake in addition to GFD

Sideral forte® matching PLACEBO drops DIETARY_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 drops for oral intake in addition to GFD

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of CD according to the current European ESPGHAN guidelines (clinical or histological) with confirmed hypoferritinemia or iron deficiency anemia.
• Age at diagnosis of CD between 8 and 18 years (inclusive).
• 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.
• Patients who have not already started GFD before diagnosis.
• Patients (and parents/legal guardian) able to understand and willing to participate in the study, with collaborative attitude.
• Informed consent release by both parents/legal guardian.

You may not qualify if:

• Potential celiac disease.
• Hb \< 8 g/dL at screening
• Other causes of anemia, hemoglobinopathies or coagulopathies.
• Active bleeding or surgery or major trauma in the last 6 months.
• Other inflammatory diseases, neoplasms or IgE mediated food allergies
• Syndromes or presence of vascular malformations
• Pregnant or lactating patients (based on self-certification by the parents and by the patient, where applicable)\*
• Patients with known or suspected allergy or hypersensitivity to the study products or any of their excipients.
• Taking oral iron-based medications in the 30 days prior to diagnosis and intravenous iron-based medications in the 90 days prior to diagnosis.
• Use of other investigational drug(s) within 30 days before study entry or during the study.
• 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.

Sponsors & Collaborators

• Istituto Giannina Gaslini: lead
• Pharmanutra S.p.a.: collaborator

Study Sites (1)

IRCCS Istituto Giannina Gaslini, pad 16

Genova, Italy, 16143, Italy

RECRUITING

Related Publications (21)

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MeSH Terms

Conditions

Anemia; Iron Deficiencies

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Marco Crocco, MD, PhD

CONTACT

+3901056362350; marcocrocco@gaslini.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Patients will be randomly assigned to one of the following treatment groups: * Sideral forte verum drops for oral intake in addition to GFD. * Sideral forte matching placebo drops for oral intake in addition to GFD. Randomization will be stratified in order to reach a balanced enrolment between patients with hypoferritinemia and patients with anemia due to iron deficiency. Patients will start the study treatment simultaneously with GFD start, after their eligibility is confirmed at Visit 1 (screening) and will continue for 6 months. All patients will be treated with GFD that, so far, is considered the Standard of Care for CD. The Principal Investigator will receive a study treatment identification key in the form of a sealed envelope containing the kit number (i.e. Kit code A-004 or Kit code B-001, etc.) and the corresponding treatment. The envelope may be opened only in case of an emergency where the identification of the study treatment assigned to the patient needs to be disclosed
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, placebo controlled, monocenter, investigator-initiated study with two parallel groups of patients

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: May 4, 2026
• Study Start: December 23, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: from the end of study to 10 years after the end of study
• Access Criteria: Access to the Individual Participant Data (IPD) and supporting documentation will be granted to: Members of the original research team, including the principal investigator and authorized study staff. Qualified external researchers who submit a legitimate research proposal. Regulatory authorities or ethics committees if required for oversight or audit purposes. All individuals requesting access must demonstrate appropriate qualifications and agree to comply with relevant data protection and confidentiality regulations.

Locations

IT (1)