Actively Recruiting
Efficacy of Oral Sucrosomial Iron Supplementation in Children With Celiac Disease and Iron Deficiency or Anemia
Led by Istituto Giannina Gaslini · Updated on 2026-05-04
60
Participants Needed
1
Research Sites
88 weeks
Total Duration
On this page
Sponsors
I
Istituto Giannina Gaslini
Lead Sponsor
P
Pharmanutra S.p.a.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Efficacy of Oral Sucrosomial Iron Supplementation in Children With Celiac Disease and Iron Deficiency or Anemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with celiac disease according to current European ESPGHAN guidelines with confirmed hypoferritinemia or iron deficiency anemia
- Age between 8 and 18 years inclusive at diagnosis
- No oral iron supplementation in the 30 days before diagnosis and no intravenous iron supplementation in the 90 days before diagnosis
- Not started a gluten-free diet before diagnosis
- Other causes of anemia excluded
- Patient and parents/legal guardian able to understand and willing to participate with a collaborative attitude
- Informed consent obtained from both parents/legal guardian
You will not qualify if you...
- Potential celiac disease
- Hemoglobin less than 8 g/dL at screening
- Other causes of anemia, hemoglobinopathies, or coagulopathies
- Active bleeding, surgery, or major trauma in the last 6 months
- Other inflammatory diseases, neoplasms, or IgE-mediated food allergies
- Syndromes or vascular malformations present
- Pregnant or lactating patients (self-certified)
- Known or suspected allergy to study products or their ingredients
- Oral iron use in the 30 days before diagnosis or intravenous iron use in the 90 days before diagnosis
- Use of other investigational drugs within 30 days before or during the study
- Any other condition or treatment making the patient unsuitable according to the Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
IRCCS Istituto Giannina Gaslini, pad 16
Genova, Italy, Italy, 16143
Actively Recruiting
Research Team
M
Marco Crocco, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here