Efficacy of Oral Sucrosomial Iron Supplementation in Children With Celiac Disease and Iron Deficiency or Anemia
A legfontosabb adatok
- Ki végzi
- Istituto Giannina Gaslini
- Hol
- Olaszország1 helyszín, 1 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Toboroz
- Résztvevők
- 60 fő, tervezett
- Kezdés
- 2025. dec. 23.
- Várható befejezés
- 2027. szept.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoportAz egyik csoport placebót (hatóanyag nélküli szert) kap, összehasonlításként.
- A vizsgált kezelések
- Sideral forte® VERUM drops
- Sideral forte® matching PLACEBO drops
- A regiszteradat frissítve
- 2026. május 4.
Ki vehet részt
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
The trial is looking for children and teenagers newly diagnosed with celiac disease who also have low iron stores or anemia caused by low iron.
- Életkor
- 8 to 18 years at diagnosis of celiac disease (inclusive).
- Nem
- All sexes can join.
- A betegség stádiuma
- Newly diagnosed celiac disease, confirmed by the current European ESPGHAN guidelines. Low ferritin (iron stores) or anemia due to iron deficiency must be confirmed.
- Korábbi kezelés
- No iron taken by mouth in the 30 days before diagnosis. No iron by vein in the 90 days before diagnosis. People must not have started a gluten-free diet before diagnosis.
- Biomarker vagy leletérték
- Confirmed low ferritin (hypoferritinemia) or iron deficiency anemia. Hb must not be below 8 g/dL at screening.
A részvétel fő kizáró okai
- Potential celiac disease, or other causes of anemia, blood disorders of hemoglobin or clotting problems.
- Active bleeding, surgery or major injury in the last 6 months.
- Other inflammatory diseases, cancers, IgE mediated food allergies, syndromes or vascular malformations.
- Pregnant or breastfeeding.
- Allergy to the study products, or use of other study drugs within 30 days before entry.
A regiszter feltételei, szó szerint
Mind a 18 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- 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
- Potential celiac disease
- 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
- Patients with known or suspected allergy or hypersensitivity to the study products or any of their excipients
- 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
- Hb < 8 g/dL at screening
- Other causes of anemia, hemoglobinopathies or coagulopathies
- Pregnant or lactating patients (based on self-certification by the parents and by the patient, where applicable)*
Nézd meg, megfelelhetsz-e
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 8 és 18 év között vagy?
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A teljes eredeti leírásKevesebb
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).
A vizsgálat 2 csoportja
- Sideral forte® VERUM drops for oral intake in addition to GFDA vizsgált kezelés
Kezelés: Sideral forte® VERUM drops
- Sideral forte® matching PLACEBO drops for oral intake in addition to GFDPlacebo, összehasonlításként
Kezelés: Sideral forte® matching PLACEBO drops
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Efficacy of Oral Sucrosomial Iron Supplementation in Children With Celiac Disease and Iron Deficiency or Anemia: a Double-blind, Randomized, Placebo-controlled Trial
- MI-összefoglaló
- A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 14.
- Illeszkedési kérdések
- Forrás: NCT07563582: ki vehet részt
- A regiszteradat frissítve
- 2026. május 4.