Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New iron supplement could help celiac kids recover faster

NCT ID NCT07563582

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

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

8 to 18 years

Sex

Anyone

Healthy volunteers

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

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Anemia are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • IRCCS Istituto Giannina Gaslini, pad 16

    RECRUITING

    Genova, Italy, 16143, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.