New iron supplement could help celiac kids recover faster
NCT ID NCT07563582
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a special type of iron supplement (Sucrosomial iron) helps children with celiac disease who also have low iron or anemia. The trial will compare children who take the supplement plus a gluten-free diet to those who only follow the diet. The goal is to see if the supplement speeds up the return of normal iron levels and hemoglobin.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Sucrosomial iron (Sideral forte® VERUM drops)
- What this could lead to
- If it works, this could provide a faster way to correct iron deficiency and anemia in children with celiac disease, improving growth and development.
- What could go wrong
- This is a small early-stage trial with only 60 participants, so results may not apply to all children. The supplement may not work better than diet alone, and some children may still have side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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8 to 18 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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IRCCS Istituto Giannina Gaslini, pad 16
RECRUITINGGenova, Italy, 16143, Italy
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- One bite of gluten: scientists track the immune alarm in celiac disease
- Could A2 milk ease gut symptoms in teens with celiac disease?
- Can starting iron sooner protect preterm babies on donor milk?
- Can IV iron boost blood levels and daily energy for mothers before and after delivery?
- Iron boost before heart surgery may cut need for donor blood
- Can treating anemia before pregnancy stop it later?