Sucrosomial iron for children with celiac disease and iron deficiency

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• IRCCS Istituto Giannina Gaslini, pad 16
  Genova, Italy, Italy Recruiting

Study contacts

• Study coordinator: Marco Crocco, MD, PhD
• Email: marcocrocco@gaslini.org
• Phone: +3901056362350

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.