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NCT Number: NCT07563582

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

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).

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Key information

Conditions

Celiac Disease in Children Anemia Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Istituto Giannina Gaslini, pad 16

Genova, Italy, 16143

Location status: Recruiting

Location contact

Marco Crocco, MD, PhD

CONTACT

[email protected]

+3901056363620

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion 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.

Exclusion criteria

  • 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.

Treatment and study plan

Sideral forte® VERUM drops

Dietary Supplement

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.

Sideral forte® matching PLACEBO drops

Dietary Supplement

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.

Primary outcomes

  1. Time to normalization of iron status

    Time frame: 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.

Secondary outcomes

  1. Change in hemoglobin

    Time frame: 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.

  2. Change in serum ferritin

    Time frame: 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.

  3. Change in mean corpuscular volume (MCV)

    Time frame: 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.

  4. Change in mean corpuscular hemoglobin (MCH)

    Time frame: 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.

  5. Change in mean corpuscular hemoglobin concentration (MCHC)

    Time frame: 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.

  6. Change in reticulocyte count

    Time frame: 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.

  7. Change in serum iron

    Time frame: 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.

  8. Change in transferrin saturation

    Time frame: 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.

  9. Change in vitamin B12

    Time frame: 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.

  10. Change in folate

    Time frame: 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.

  11. Change in fatigue score assessed by PedsQL™ Multidimensional Fatigue Scale

    Time frame: 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.

  12. Changes from baseline in disease-specific quality of life measured by Coeliac Disease Dutch Questionnaire (CDDUX)

    Time frame: 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.

  13. Changes from baseline in generic health-related quality of life measured by Pediatric Quality of Life Inventory (PedsQL™ 4.0)

    Time frame: 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.

  14. Adherence to GFD

    Time frame: 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.

  15. Changes from baseline in gastrointestinal symptoms assessed with PedsQL™ 3.0 Gastrointestinal Symptoms Module score

    Time frame: 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.

  16. Number and proportion of participants with treatment-related adverse events, graded according to CTCAE v5.0, during Sucrosomial® iron supplementation

    Time frame: 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.

Other outcomes

  1. Changes from baseline in inflammatory biomarkers

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marco Crocco, MD, PhD

CONTACT

[email protected]

+3901056362350

Sponsors and collaborators

Lead sponsor

Istituto Giannina Gaslini

Other

Collaborators

  • Pharmanutra S.p.a.

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 4, 2026
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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