Efficacy of Oral Sucrosomial Iron Supplementation in Children With Celiac Disease and Iron Deficiency or Anemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-18
SponsorIstituto Giannina Gaslini
About this 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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Sideral forte® VERUM drops
Dietary supplementPatients 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® VERUM drops
Dietary supplementPatients 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.
Sideral forte® matching PLACEBO drops
Dietary supplementPatients 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.
Sideral forte® matching PLACEBO drops
Dietary supplementPatients 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Sideral forte® VERUM drops for oral intake in addition to GFDExperimental treatment 1 intervention
Group B: Sideral forte® matching PLACEBO drops for oral intake in addition to GFDPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time to normalization of iron status
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.
Time frame
From enrollment to the end of the treatment at 6 monthsSecondary outcomes
1
Change in hemoglobin
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.
Time frame
Baseline to 6 months2
Change in serum ferritin
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.
Time frame
Baseline to 6 months3
Change in mean corpuscular volume (MCV)
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.
Time frame
Baseline to 6 months4
Change in mean corpuscular hemoglobin (MCH)
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.
Time frame
Baseline to 6 monthsOther outcomes
1
Changes from baseline in inflammatory biomarkers
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.
Time frame
From enrollment to the end of the treatment at 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Istituto Giannina Gaslini
Lead sponsor
Pharmanutra S.p.a.
Collaborator
Source ClinicalTrials.gov