An interventional study of Sideral forte® VERUM drops and Sideral forte® VERUM drops in Celiac Disease in Children, Anemia and Iron Deficiencies, sponsored by Istituto Giannina Gaslini. Recruiting at 1 site in Italy. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by Istituto Giannina Gaslini · Not applicable, Interventional, and Treatment
Among 119 studies in Anemia with a site in Italy — 11 open to participants now, 23 under way, 14 of them phase 3. Anemia · Italy.
Among the 119 studies in Anemia with a site in Italy, this one is the 81st largest by planned enrollment of the 99 interventional ones that give a count, is one of 4 that started in 2025, is one of 8 with no phase, reaches primary completion later than 9 of the 22 other live ones, and was the 117th registered.
1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.
This study's planned enrollment of 60 is below the median of 117 across 1,336 interventional studies indexed under Anemia.
Browse Anemia studies →11 of the 119 studies in Anemia with a site in Italy are open now.
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 122 Anemia studies recruiting now, 67 (55%) set no upper age limit and 37 (30%) stop at 75 or younger; 34 take children under 18; 23 take healthy volunteers.
This study: 8 Years to 18 Years · all sexes · no healthy volunteers.
The full table on the hub →119 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 29 · Phase 3 59 · Phase 4 4
First in 2000; this study’s year is marked. 4 started in 2025.
Median enrollment 228 across the 99 interventional studies, 308 across the 19 observational. Of the 87 that completed or were terminated, 56 (64%) have results posted.
92 of 119 have an industry lead sponsor. The 10 most frequent:
Istituto Giannina Gaslini is the lead sponsor of 54 studies on the registry; 36 are open to participants now.
Istituto Giannina Gaslini has 1 study filed under Anemia — fewer than ten, so there is no comparison to draw.
7 of the studies in Anemia with a site in Italy that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06466785Phase 3Genexine, Inc.A Phase 3 Study of Efepoetin Alfa for Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis | 2027-06 |
| NCT04747613Phase 3Novartis PharmaceuticalsLong-term Safety and Tolerability of Iptacopan in Patients With Paroxysmal Nocturnal Hemoglobinuria | 2027-10-18 |
| NCT05970172Phase 3Astellas Pharma Global Development, Inc.A Study of Roxadustat to Treat Anemia in Children and Teenagers With Chronic Kidney Disease | 2027-10-30 |
| NCT06637137Fondazione Policlinico Universitario Agostino Gemelli IRCCSPatient Blood Management in Patients Scheduled for Cardiac Surgery | 2027-02-28 |
| NCT07563582Istituto Giannina GasliniEfficacy of Oral Sucrosomial Iron Supplementation in Children With Celiac Disease and Iron Deficiency or Anemia | 2027-03 |
Among the 119 studies in Anemia with a site in Italy, from their registry updates:
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:
The age of patients will also be considered for the randomization (to assign the correct number of product bottles).
Inclusion Criteria:
Exclusion Criteria:
Any other condition, illness or treatment that in the Investigator's opinion does not make the patient suitable for the study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dietary Supplement: Sideral forte® VERUM drops
Dietary Supplement: Sideral forte® matching PLACEBO 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.
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.
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.
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.
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 months
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 months
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 months
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 months
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 months
Change in mean corpuscular hemoglobin concentration (MCHC)
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.
Time frame: Baseline to 6 months
Change in reticulocyte count
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.
Time frame: Baseline to 6 months
Change in serum iron
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.
Time frame: Baseline to 6 months
Change in transferrin saturation
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.
Time frame: Baseline to 6 months
Change in vitamin B12
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.
Time frame: Baseline to 6 months
Change in folate
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.
Time frame: Baseline to 6 months
Change in fatigue score assessed by PedsQL™ Multidimensional Fatigue Scale
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: From enrollment to the end of treatment (6 months)
Adherence to GFD
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: From enrollment to the end of the treatment at 6 months
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 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: from the end of study to 10 years after the end of study
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.
Started Dec 2025 (actual). Primary completion is estimated for Mar 2027, 15 months after the start.
Of 163 non-industry interventional studies with no phase under Anemia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 30. This study's planned 15 months is below that.
Counting every sponsor, half of 177 studies reached it within 17 months; a quarter within 7 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
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Istituto Giannina Gaslini