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

RecruitingNAAges 8 Years - 18 YearsAllIstituto Giannina Gaslini
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In plain words

What the trial is, and whether it could suit you

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 sto

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📋 Eligibility rules (as published)
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.
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What it tests

  • Sideral forte® VERUM drops
  • Sideral forte® VERUM drops
  • Sideral forte® matching PLACEBO drops
  • Sideral forte® matching PLACEBO drops
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Where

1 site
IRCCS Istituto Giannina Gaslini, pad 16
Genova, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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