Celiac Disease in ChildrenNCT07563582
Efficacy of Oral Sucrosomial Iron Supplementation in Children With Celiac Disease and Iron Deficiency or Anemia
A study testing Sideral forte® VERUM drops in people with Celiac Disease in Children and Anemia, run by Istituto Giannina Gaslini at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Celiac Disease in Children, Anemia, Iron Deficiencies
- What is being tested?
- Sideral forte® VERUM drops
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 23 Dec 2025to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Giannina Gaslini, pad 16
Genova, Italy, 16143
Marco Crocco, MD, PhD, +3901056363620, marcocrocco@gaslini.org
About this study
Official title: 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.
Read more
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).
- Conditions
- Celiac Disease in Children, Anemia, Iron Deficiencies
- Being tested
- Sideral forte® VERUM drops, Sideral forte® matching PLACEBO drops
- Keywords
- Iron deficiency/anemia due to iron deficiency in CD children and adolescents
- Medical subject headings
- Anemia, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sideral forte® VERUM dropsDietary 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® VERUM dropsDietary supplement
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.
Sideral forte® matching PLACEBO dropsDietary 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.
Sideral forte® matching PLACEBO dropsDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Sideral forte® VERUM drops for oral intake in addition to GFD | Experimental | Not described Receives: Dietary Supplement: Sideral forte® VERUM drops |
| Sideral forte® matching PLACEBO drops for oral intake in addition to GFD | Placebo comparator | Not described Receives: Dietary Supplement: Sideral forte® matching PLACEBO drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of the treatment at 6 months
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of the treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start23 Dec 2025
- Primary completionMar 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Celiac Disease in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, placebo controlled, monocenter, investigator-initiated study with two parallel groups of patients
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Giannina Gaslini
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmanutra S.p.a.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07563582
- Sponsor's protocol ID
- CD-GAS-FESUCR
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Ministero della Salute "Linee di indirizzo sugli studi condotti per valutare la sicurezza e le proprietà di prodotti alimentari" - Revisione novembre 2018.
Parisi F, Berti C, Mando C, Martinelli A, Mazzali C, Cetin I. Effects of different regimens of iron prophylaxis on maternal iron status and pregnancy outcome: a randomized control trial. J Matern Fetal Neonatal Med. 2017 Aug;30(15):1787-1792. doi: 10.1080/14767058.2016.1224841. Epub 2016 Sep 2.
PubMed 27588568Varni JW, Bendo CB, Denham J, Shulman RJ, Self MM, Neigut DA, Nurko S, Patel AS, Franciosi JP, Saps M, Verga B, Smith A, Yeckes A, Heinz N, Langseder A, Saeed S, Zacur GM, Pohl JF. PedsQL gastrointestinal symptoms module: feasibility, reliability, and validity. J Pediatr Gastroenterol Nutr. 2014 Sep;59(3):347-55. doi: 10.1097/MPG.0000000000000414.
PubMed 24806837Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.
PubMed 11468499van Doorn RK, Winkler LM, Zwinderman KH, Mearin ML, Koopman HM. CDDUX: a disease-specific health-related quality-of-life questionnaire for children with celiac disease. J Pediatr Gastroenterol Nutr. 2008 Aug;47(2):147-52. doi: 10.1097/MPG.0b013e31815ef87d.
PubMed 18664865Varni JW, Burwinkle TM, Katz ER, Meeske K, Dickinson P. The PedsQL in pediatric cancer: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module. Cancer. 2002 Apr 1;94(7):2090-106. doi: 10.1002/cncr.10428.
PubMed 11932914Corazza GR, Villanacci V. Coeliac disease. J Clin Pathol. 2005 Jun;58(6):573-4. doi: 10.1136/jcp.2004.023978. No abstract available.
PubMed 15917404Oberhuber G, Granditsch G, Vogelsang H. The histopathology of coeliac disease: time for a standardized report scheme for pathologists. Eur J Gastroenterol Hepatol. 1999 Oct;11(10):1185-94. doi: 10.1097/00042737-199910000-00019.
PubMed 10524652Ludvigsson JF, Leffler DA, Bai JC, Biagi F, Fasano A, Green PH, Hadjivassiliou M, Kaukinen K, Kelly CP, Leonard JN, Lundin KE, Murray JA, Sanders DS, Walker MM, Zingone F, Ciacci C. The Oslo definitions for coeliac disease and related terms. Gut. 2013 Jan;62(1):43-52. doi: 10.1136/gutjnl-2011-301346. Epub 2012 Feb 16.
PubMed 22345659Elli L, Ferretti F, Branchi F, Tomba C, Lombardo V, Scricciolo A, Doneda L, Roncoroni L. Sucrosomial Iron Supplementation in Anemic Patients with Celiac Disease Not Tolerating Oral Ferrous Sulfate: A Prospective Study. Nutrients. 2018 Mar 9;10(3):330. doi: 10.3390/nu10030330.
PubMed 29522446Repo M, Lindfors K, Maki M, Huhtala H, Laurila K, Lahdeaho ML, Saavalainen P, Kaukinen K, Kurppa K. Anemia and Iron Deficiency in Children With Potential Celiac Disease. J Pediatr Gastroenterol Nutr. 2017 Jan;64(1):56-62. doi: 10.1097/MPG.0000000000001234.
PubMed 27101536Mearin ML, Agardh D, Antunes H, Al-Toma A, Auricchio R, Castillejo G, Catassi C, Ciacci C, Discepolo V, Dolinsek J, Donat E, Gillett P, Guandalini S, Husby Md DMSc S, Koletzko Md S, Koltai T, Korponay-Szabo IR, Kurppa K, Lionetti E, Marild K, Martinez Ojinaga E, Meijer C, Monachesi C, Polanco I, Popp A, Roca M, Rodriguez-Herrera A, Shamir R, Stordal K, Troncone R, Valitutti F, Vreugdenhil A, Wessels M, Whiting P; ESPGHAN Special Interest Group on Celiac Disease. ESPGHAN Position Paper on Management and Follow-up of Children and Adolescents With Celiac Disease. J Pediatr Gastroenterol Nutr. 2022 Sep 1;75(3):369-386. doi: 10.1097/MPG.0000000000003540. Epub 2022 Jun 27.
PubMed 35758521Annibale B, Severi C, Chistolini A, Antonelli G, Lahner E, Marcheggiano A, Iannoni C, Monarca B, Delle Fave G. Efficacy of gluten-free diet alone on recovery from iron deficiency anemia in adult celiac patients. Am J Gastroenterol. 2001 Jan;96(1):132-7. doi: 10.1111/j.1572-0241.2001.03463.x.
PubMed 11197242Montoro-Huguet MA, Santolaria-Piedrafita S, Canamares-Orbis P, Garcia-Erce JA. Iron Deficiency in Celiac Disease: Prevalence, Health Impact, and Clinical Management. Nutrients. 2021 Sep 28;13(10):3437. doi: 10.3390/nu13103437.
PubMed 34684433Harper JW, Holleran SF, Ramakrishnan R, Bhagat G, Green PH. Anemia in celiac disease is multifactorial in etiology. Am J Hematol. 2007 Nov;82(11):996-1000. doi: 10.1002/ajh.20996.
PubMed 17636474
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oral Sucrosomial Iron Supplementation in Children With Celiac Disease and Iron Deficiency or Anemia: a Double-blind, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT07563582
- Acronym / sponsor ID
- CD-GAS-FESUCR
- Conditions
- Celiac Disease in Children, Anemia, Iron Deficiencies
- Keywords
- Iron deficiency/anemia due to iron deficiency in CD children and adolescents
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istituto Giannina GasliniUniversity, hospital or other
- Collaborators
- Pharmanutra S.p.a.
- Study start
- 23 Dec 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- randomized, placebo controlled, monocenter, investigator-initiated study with two parallel groups of patients
| Arm | Type | Receives |
|---|---|---|
| Sideral forte® VERUM drops for oral intake in addition to GFD | Experimental | Dietary Supplement: Sideral forte® VERUM drops |
| Sideral forte® matching PLACEBO drops for oral intake in addition to GFD | Placebo comparator | Dietary Supplement: Sideral forte® matching PLACEBO drops |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sideral forte® VERUM dropsPatients 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 for oral intake in addition to GFD |
| Sideral forte® VERUM dropsPatients 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. | Dietary supplement | Sideral forte® VERUM drops for oral intake in addition to GFD |
| Sideral forte® matching PLACEBO dropsPatients 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 for oral intake in addition to GFD |
| Sideral forte® matching PLACEBO dropsPatients 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. | Dietary supplement | Sideral forte® matching PLACEBO drops for oral intake in addition to GFD |
Primary outcome
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.
16 secondary outcomes
Change in hemoglobin
Time frame: Baseline to 6 months
Change in serum ferritin
Time frame: Baseline to 6 months
Change in mean corpuscular volume (MCV)
Time frame: Baseline to 6 months
Change in mean corpuscular hemoglobin (MCH)
Time frame: Baseline to 6 months
Change in mean corpuscular hemoglobin concentration (MCHC)
Time frame: Baseline to 6 months
Change in reticulocyte count
Time frame: Baseline to 6 months
Change in serum iron
Time frame: Baseline to 6 months
Change in transferrin saturation
Time frame: Baseline to 6 months
Change in vitamin B12
Time frame: Baseline to 6 months
Change in folate
Time frame: 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
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
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)
Adherence to GFD
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
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
Time frame: From enrollment to the end of the treatment at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- BackgroundMinistero della Salute "Linee di indirizzo sugli studi condotti per valutare la sicurezza e le proprietà di prodotti alimentari" - Revisione novembre 2018.
- Background: PubMed 27588568Parisi F, Berti C, Mando C, Martinelli A, Mazzali C, Cetin I. Effects of different regimens of iron prophylaxis on maternal iron status and pregnancy outcome: a randomized control trial. J Matern Fetal Neonatal Med. 2017 Aug;30(15):1787-1792. doi: 10.1080/14767058.2016.1224841. Epub 2016 Sep 2.
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- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sideral forte® VERUM drops in people with Celiac Disease in Children and Anemia, run by Istituto Giannina Gaslini at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marco Crocco, MD, PhD (+3901056362350, marcocrocco@gaslini.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to normalization of iron status (time frame: From enrollment to the end of the treatment at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07563582, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.