Efficacy of Oral Sucrosomial Iron Supplementation in Children With Celiac Disease and Iron Defici… (NCT07563582) | Clinical Trial Compass
RecruitingNot Applicable
Efficacy of Oral Sucrosomial Iron Supplementation in Children With Celiac Disease and Iron Deficiency or Anemia
Italy60 participantsStarted 2025-12-23
Plain-language 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).
Who can participate
Age range
8 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. Patients (and parents/legal guardian) able to understand and willing to participate in the study, with collaborative attitude.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is specifically testing oral sucrosomial iron in children with celiac disease who have iron deficiency or anemia, would my child's current level of iron deficiency make them a reasonable candidate to discuss for this study?
2How does sucrosomial iron differ from the standard iron supplements my child might already be prescribed, and why might it matter specifically for a child with celiac disease whose gut absorption may be impaired?
3This trial is measuring how long it takes for iron levels to return to normal — what does that timeline typically look like with standard treatment, and how might participating in this study compare to just starting regular iron supplementation now?
4Because celiac disease itself needs to be managed with a gluten-free diet to allow gut healing, how would participation in this trial interact with the dietary changes my child is already supposed to be making?
5Are there any risks specific to oral iron supplementation in children with active celiac disease that I should understand before deciding whether to ask about enrolling my child in this study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to normalization of iron status
Timeframe: From enrollment to the end of the treatment at 6 months