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

April 29, 2026 updated by: 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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Italy
      • Genova, Italy, Italy, 16143
        • Recruiting
        • IRCCS Istituto Giannina Gaslini, pad 16
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sideral forte® VERUM drops for oral intake in addition to GFD
Dietary supplement: 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.
Dietary supplement: 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 Comparator: Sideral forte® matching PLACEBO drops for oral intake in addition to GFD
Dietary supplement: 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.
Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of the treatment at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 6 months
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.
Baseline to 6 months
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.
Baseline to 6 months
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.
Baseline to 6 months
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.
Baseline to 6 months
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.
Baseline to 6 months
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.
Baseline to 6 months
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.
Baseline to 6 months
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.
Baseline to 6 months
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.
Baseline to 6 months
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.
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)
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.
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)
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.
From enrollment to the end of treatment (6 months)
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.
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
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.
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
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.
From enrollment to the end of the treatment at 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of the treatment at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Giannina Gaslini

Collaborators

Pharmanutra S.p.a.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

April 2, 2026

First Submitted That Met QC Criteria

April 29, 2026

First Posted (Actual)

May 4, 2026

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD-GAS-FESUCR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

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

IPD Sharing Access Criteria

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 Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anemia

Clinical Trials on Sideral forte® VERUM drops

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe