Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Efficacy of Oral Sucrosomial Iron Supplementation in Children With Celiac Disease and Iron Deficiency or Anemia

29. april 2026 opdateret af: Istituto Giannina Gaslini

Efficacy of Oral Sucrosomial Iron Supplementation in Children With Celiac Disease and Iron Deficiency or Anemia: a Double-blind, Randomized, Placebo-controlled Trial

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).

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Italien
    • Italy
      • Genova, Italy, Italien, 16143
        • Rekruttering
        • IRCCS Istituto Giannina Gaslini, pad 16
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Sideral forte® VERUM drops for oral intake in addition to GFD
Kosttilskud: Sideral forte® VERUM drops

Patients with hypoferritinemia (no anemia):

  • From 8 years until development (Tanner stage <=3): 1 ml of Sideral forte® VERUM drops, equal to 14 mg of iron element;
  • From development (Tanner stage >3) up to 18 years: 2 ml of Sideral forte® VERUM drops, equal to 28 mg of iron element.
Kosttilskud: Sideral forte® VERUM drops

Patients with anemia due to iron deficiency:

  • From 8 years until development (Tanner stage <=3): 2 ml of Sideral forte® VERUM drops, equal to 28 mg of iron element;
  • From development (Tanner stage >3) up to 18 years: 3 ml of SiderAL FORTE oral drops, equal to 42 mg of iron element.
Placebo komparator: Sideral forte® matching PLACEBO drops for oral intake in addition to GFD
Kosttilskud: Sideral forte® matching PLACEBO drops

Patients with hypoferritinemia (no anemia):

  • From 8 years until development (Tanner stage <=3): 1 ml/day of PLACEBO drops;
  • From development (Tanner stage >3) up to 18 years: 2 ml/day of of PLACEBO drops.
Kosttilskud: Sideral forte® matching PLACEBO drops

Patients with anemia due to iron deficiency:

  • From 8 years until development (Tanner stage <=3): 2 ml of PLACEBO drops;
  • From development (Tanner stage >3) up to 18 years: 3 ml of PLACEBO drops.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to normalization of iron status
Tidsramme: From enrollment to the end of the treatment at 6 months

Time from baseline (defined as the time from diagnosis of celiac disease) to the first documented normalization of iron status.

Normalization is defined as:

  • hemoglobin (Hb) within age- and sex-specific reference ranges in participants with iron deficiency anemia at baseline, or
  • serum ferritin within reference ranges in participants with isolated hypoferritinemia at baseline

Comparisons will be performed between participants receiving oral Sucrosomial® iron supplementation plus a gluten-free diet (GFD) and those receiving GFD alone.
From enrollment to the end of the treatment at 6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in hemoglobin
Tidsramme: Baseline to 6 months
Change in hemoglobin (Hb) levels (gr/dl) from baseline to 6 months. Comparisons will be performed between participants receiving oral Sucrosomial® iron supplementation plus a gluten-free diet (GFD) and those receiving GFD alone.
Baseline to 6 months
Change in serum ferritin
Tidsramme: Baseline to 6 months
Change in serum ferritin levels (ng/ml) from baseline to 6 months. Comparisons will be performed between participants receiving oral Sucrosomial® iron supplementation plus a gluten-free diet (GFD) and those receiving GFD alone.
Baseline to 6 months
Change in mean corpuscular volume (MCV)
Tidsramme: Baseline to 6 months
Change in mean corpuscular volume (MCV) (fL) from baseline to 6 months. Comparisons will be performed between participants receiving oral Sucrosomial® iron supplementation plus a gluten-free diet (GFD) and those receiving GFD alone.
Baseline to 6 months
Change in mean corpuscular hemoglobin (MCH)
Tidsramme: Baseline to 6 months
Change in mean corpuscular hemoglobin (MCH) (pg) from baseline to 6 months. Comparisons will be performed between participants receiving oral Sucrosomial® iron supplementation plus a gluten-free diet (GFD) and those receiving GFD alone.
Baseline to 6 months
Change in mean corpuscular hemoglobin concentration (MCHC)
Tidsramme: Baseline to 6 months
Change in mean corpuscular hemoglobin concentration (MCHC) (g/L) from baseline to 6 months. Comparisons will be performed between participants receiving oral Sucrosomial® iron supplementation plus a gluten-free diet (GFD) and those receiving GFD alone.
Baseline to 6 months
Change in reticulocyte count
Tidsramme: Baseline to 6 months
Change in reticulocyte count (reticulocyte/mmc) from baseline to 6 months. Comparisons will be performed between participants receiving oral Sucrosomial® iron supplementation plus a gluten-free diet (GFD) and those receiving GFD alone.
Baseline to 6 months
Change in serum iron
Tidsramme: Baseline to 6 months
Change in serum iron levels (ug/dl) from baseline to 6 months. Comparisons will be performed between participants receiving oral Sucrosomial® iron supplementation plus a gluten-free diet (GFD) and those receiving GFD alone.
Baseline to 6 months
Change in transferrin saturation
Tidsramme: Baseline to 6 months
Change in transferrin saturation (%) from baseline to 6 months. Comparisons will be performed between participants receiving oral Sucrosomial® iron supplementation plus a gluten-free diet (GFD) and those receiving GFD alone.
Baseline to 6 months
Change in vitamin B12
Tidsramme: Baseline to 6 months
Change in vitamin B12 levels (pg/ml) from baseline to 6 months. Comparisons will be performed between participants receiving oral Sucrosomial® iron supplementation plus a gluten-free diet (GFD) and those receiving GFD alone.
Baseline to 6 months
Change in folate
Tidsramme: Baseline to 6 months
Change in folate levels (ng/ml) from baseline to 6 months. Comparisons will be performed between participants receiving oral Sucrosomial® iron supplementation plus a gluten-free diet (GFD) and those receiving GFD alone.
Baseline to 6 months
Change in fatigue score assessed by PedsQL™ Multidimensional Fatigue Scale
Tidsramme: From enrollment to the end of the treatment at 6 months

Change from baseline to 6 months in fatigue, assessed using the PedsQL™ Multidimensional Fatigue Scale total score.

The PedsQL™ Multidimensional Fatigue Scale is a validated pediatric questionnaire available in age-appropriate versions. Scores range from 0 to 100, with higher scores indicating lower levels of fatigue.

Comparisons will be performed between participants receiving oral Sucrosomial® iron supplementation plus a gluten-free diet (GFD) and those receiving GFD alone.
From enrollment to the end of the treatment at 6 months
Changes from baseline in disease-specific quality of life measured by Coeliac Disease Dutch Questionnaire (CDDUX)
Tidsramme: From enrollment to the end of the treatment at 6 months
To evaluate the effect of oral supplementation with Sucrosomial® iron, as an add-on to a gluten-free diet (GFD), compared with placebo, on disease-specific quality of life in pediatric patients with celiac disease. Quality of life will be assessed using the Coeliac Disease Dutch Questionnaire (CDDUX). Scores will be transformed to a standardized 0-100 scale, with higher scores indicating better quality of life. Changes from baseline to each follow-up time point will be analyzed and compared between treatment groups.
From enrollment to the end of the treatment at 6 months
Changes from baseline in generic health-related quality of life measured by Pediatric Quality of Life Inventory (PedsQL™ 4.0)
Tidsramme: From enrollment to the end of treatment (6 months)
To evaluate the effect of oral supplementation with Sucrosomial® iron, as an add-on to a gluten-free diet (GFD), compared with placebo, on generic health-related quality of life in pediatric patients. Quality of life will be assessed using the Pediatric Quality of Life Inventory (PedsQL™ 4.0). Scores will be transformed to a standardized 0-100 scale, with higher scores indicating better quality of life. Changes from baseline to each follow-up time point will be analyzed and compared between treatment groups.
From enrollment to the end of treatment (6 months)
Adherence to GFD
Tidsramme: From enrollment to the end of the treatment at 6 months

To evaluate the adherence to the GFD in patients without Sucrosomial® iron supplementation compared to placebo group.

The adherence to GFD and to treatment will be assessed with interview during visits and with dietary diary.
From enrollment to the end of the treatment at 6 months
Changes from baseline in gastrointestinal symptoms assessed with PedsQL™ 3.0 Gastrointestinal Symptoms Module score
Tidsramme: From enrollment to the end of the treatment at 6 months

To evaluate the modifications from baseline to each follow-up time point in the PedsQL™ 3.0 Gastrointestinal Symptoms Module score, and to compare the two treatment groups.

The PedsQL™ 3.0 Gastrointestinal Symptoms Module is a disease-specific instrument designed to evaluate gastrointestinal symptoms in pediatric patients. It is scored on a 0-100 scale, with higher scores indicating fewer gastrointestinal symptoms.
From enrollment to the end of the treatment at 6 months
Number and proportion of participants with treatment-related adverse events, graded according to CTCAE v5.0, during Sucrosomial® iron supplementation
Tidsramme: From enrollment to the end of the treatment at 6 months
To evaluate the safety of Sucrosomial® iron supplementation in pediatric patients with hypoferritinemia and/or iron deficiency anemia at the onset of celiac disease. Adverse events will be collected throughout the study period and classified by type, severity (graded according to CTCAE v5.0 criteria), and relationship to the treatment. Gastrointestinal adverse events (e.g., abdominal pain, diarrhea, constipation, nausea) will be specifically recorded. Data will be summarized as the number and proportion of participants experiencing: (1) any adverse event, (2) treatment-related adverse events, and (3) gastrointestinal adverse events. Serious adverse events will be reported separately.
From enrollment to the end of the treatment at 6 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes from baseline in inflammatory biomarkers
Tidsramme: From enrollment to the end of the treatment at 6 months

Exploratory objectives and endpoints. To evaluate the effects of oral supplementation with Sucrosomial® iron as an add-on to the GFD in pediatric patients with hypoferritinemia and/or iron deficiency anemia at the onset of celiac disease on inflammatory biomarkers.

The inflammatory biomarkers (IL-6, IL-10, alpha TNF, serum zonulin) will be assessed from baseline to each time point, in the two treatment groups.
From enrollment to the end of the treatment at 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Istituto Giannina Gaslini

Samarbejdspartnere

Pharmanutra S.p.a.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

23. december 2025

Primær færdiggørelse (Anslået)

1. marts 2027

Studieafslutning (Anslået)

1. september 2027

Datoer for studieregistrering

Først indsendt

2. april 2026

Først indsendt, der opfyldte QC-kriterier

29. april 2026

Først opslået (Faktiske)

4. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CD-GAS-FESUCR

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-delingstidsramme

from the end of study to 10 years after the end of study

IPD-delingsadgangskriterier

Access to the Individual Participant Data (IPD) and supporting documentation will be granted to:

Members of the original research team, including the principal investigator and authorized study staff.

Qualified external researchers who submit a legitimate research proposal.

Regulatory authorities or ethics committees if required for oversight or audit purposes.

All individuals requesting access must demonstrate appropriate qualifications and agree to comply with relevant data protection and confidentiality regulations.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Anæmi

Kliniske forsøg med Sideral forte® VERUM drops

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Uganda

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner