Sucrosomial iron for children with celiac disease and iron deficiency

Efficacy of Oral Sucrosomial Iron Supplementation in Children With Celiac Disease and Iron Deficiency or Anemia: a Double-blind, Randomized, Placebo-controlled Trial

This trial tests whether adding oral Sucrosomial® (Sideral forte®) iron drops to a gluten-free diet helps children aged 8–18 with newly diagnosed celiac disease and low iron or anemia recover hemoglobin and iron stores faster than diet alone.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 8 Years to 18 Years
• Sex: All
• Sponsor: Istituto Giannina Gaslini (other)
• Locations: 1 site (Genova, Italy)
• Trial ID: NCT07563582 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled trial enrolling children aged 8–18 with newly diagnosed celiac disease and confirmed hypoferritinemia or iron deficiency anemia. Participants who have not yet started a gluten-free diet are randomized to receive oral Sucrosomial® iron drops (Sideral forte®) or matching placebo drops in addition to beginning a gluten-free diet. Clinical visits include periodic blood tests to monitor hemoglobin, ferritin and other iron parameters, along with recording adverse events and tolerability. The study compares the speed and safety of iron normalization between the supplemented and placebo groups.

Who should consider this trial

Good fit: Children aged 8–18 with newly diagnosed celiac disease who have low ferritin or iron deficiency anemia, have not started a gluten-free diet, and have not received recent oral (past 30 days) or IV (past 90 days) iron, with parental consent, are ideal candidates.

Not a fit: Children with very severe anemia (hemoglobin < 8 g/dL), other causes of anemia (including hemoglobinopathies), active inflammatory or neoplastic disease, recent major bleeding or surgery, or those already on a gluten-free diet or recent iron therapy are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, supplementation could enable children to reach normal hemoglobin and iron stores more quickly, potentially reducing risks to growth and neurodevelopment.

How similar studies have performed: Sucrosomial® iron has shown improved absorption and gastrointestinal tolerability in adult celiac patients, but pediatric data are limited so this approach is only partially validated in children.

Eligibility criteria

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.

Where this trial is running

Genova, Italy

• IRCCS Istituto Giannina Gaslini, pad 16 — Genova, Italy, Italy (RECRUITING)

Study contacts

• Study coordinator: Marco Crocco, MD, PhD

Conditions: Celiac Disease in Children, Anemia, Iron Deficiencies, Iron deficiency/anemia due to iron deficiency in CD children and adolescents