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Tests treatment safety and results for Celiac Disease in Children
Official title Efficacy of Oral Sucrosomial Iron Supplementation in Children With Celiac Disease and Iron Deficiency or Anemia
ClinicalTrials.gov ID: NCT07563582
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 18
You may be able to join if
- Diagnosis of CD according to the current European ESPGHAN guidelines (clinical or histological) with confirmed hypoferritinemia or iron deficiency...
- 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...
- Patients who have not already started GFD before diagnosis.
- Exclusion of other causes of anemia.
You likely can't join if
- Potential celiac disease.
- Hb \< 8 g/dL at screening
- Other causes of anemia, hemoglobinopathies or coagulopathies.
- Active bleeding or surgery or major trauma in the last 6 months.
- Other inflammatory diseases, neoplasms or IgE mediated food allergies
- Syndromes or presence of vascular malformations
See the full eligibility 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 of other causes of anemia.
- Patients (and parents/legal guardian) able to understand and willing to participate in the study, with collaborative attitude.
- Informed consent release by both parents/legal guardian.
- Potential celiac disease.
- Hb \< 8 g/dL at screening
- Other causes of anemia, hemoglobinopathies or coagulopathies.
- Active bleeding or surgery or major trauma in the last 6 months.
- Other inflammatory diseases, neoplasms or IgE mediated food allergies
- Syndromes or presence of vascular malformations
- Pregnant or lactating patients (based on self-certification by the parents and by the patient, where applicable)\
- Patients with known or suspected allergy or hypersensitivity to the study products or any of their excipients.
- Taking oral iron-based medications in the 30 days prior to diagnosis and intravenous iron-based medications in the 90 days prior to diagnosis.
- Use of other investigational drug(s) within 30 days before study entry or during the study.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Genova, Italy, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Genova, Italy, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.