Iron Deficiency in Pediatric Celiac Disease: Diet vs. Iron Supplementation Trial
NCT ID: NCT06921343
Last Updated: 2025-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
150 participants
INTERVENTIONAL
2025-04-30
2028-12-31
Brief Summary
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In this study, children with newly diagnosed celiac disease and low iron levels (but normal hemoglobin) will be randomly assigned to one of two groups:
Gluten-Free Diet Only - No additional iron supplements Gluten-Free Diet + Iron Supplementation Researchers will compare iron store levels over one year to see if iron supplements provide any additional benefit beyond the gluten-free diet alone. The study will also track possible side effects of iron supplements, such as stomach discomfort.
This study will help doctors determine the best approach to managing iron deficiency in children with celiac disease, ensuring they receive the safest and most effective treatment.
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Detailed Description
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Gluten-Free Diet Alone Gluten-Free Diet + Iron Supplementation The primary objective is to determine whether a gluten-free diet alone is sufficient to restore ferritin levels or if iron supplementation provides a significant additional benefit.
Study Design \& Methods Eligible participants will be randomly assigned to one of the two treatment groups.
Ferritin levels will be monitored at baseline, 4 months, and 12 months to assess improvements.
The study will also evaluate patient adherence to a gluten-free diet and iron supplementation, quality of life, as well as the incidence of gastrointestinal side effects related to iron supplement use.
This study is expected to provide evidence-based guidance for the management of iron deficiency in pediatric celiac disease, addressing a gap in current clinical recommendations.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention group
Gluten-free diet + Oral Iron Supplementation Iron (III) Hydroxide Polymaltose (50 mg/5 mL) at a single dose of 6 mg/kg/day, maximum 100 mg/day, for 3 months
Iron (III) Hydroxide Polymaltose (50 mg/5 mL)
Participants randomized to the intervention group will receive oral iron supplementation in addition to a gluten-free diet. The specific iron formulation used in this study is Iron (III) Hydroxide Polymaltose (50 mg/5 mL) at a dosage of 6 mg/kg/day, up to a maximum of 100 mg/day, for 3 months.
The iron supplement will be given once daily, preferably on an empty stomach or with vitamin C-containing foods to enhance absorption. Parents/caregivers will be instructed on proper administration, and adherence will be monitored through weekly self-reported intake logs and pharmacy dispensing records.
This intervention is specifically targeted at children with newly diagnosed celiac disease and iron deficiency without anemia.
The study follows a non-inferiority design, comparing the effect of iron supplementation versus a gluten-free diet alone on ferritin levels.
Gluten-free diet
Participants in the control group will follow a strict gluten-free diet, the standard-of-care treatment for celiac disease. No iron supplementation will be given. Compliance will be monitored through self-reported adherence and TTG antibody levels at follow-up.
Control group
Gluten-free diet
Gluten-free diet
Participants in the control group will follow a strict gluten-free diet, the standard-of-care treatment for celiac disease. No iron supplementation will be given. Compliance will be monitored through self-reported adherence and TTG antibody levels at follow-up.
Interventions
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Iron (III) Hydroxide Polymaltose (50 mg/5 mL)
Participants randomized to the intervention group will receive oral iron supplementation in addition to a gluten-free diet. The specific iron formulation used in this study is Iron (III) Hydroxide Polymaltose (50 mg/5 mL) at a dosage of 6 mg/kg/day, up to a maximum of 100 mg/day, for 3 months.
The iron supplement will be given once daily, preferably on an empty stomach or with vitamin C-containing foods to enhance absorption. Parents/caregivers will be instructed on proper administration, and adherence will be monitored through weekly self-reported intake logs and pharmacy dispensing records.
This intervention is specifically targeted at children with newly diagnosed celiac disease and iron deficiency without anemia.
The study follows a non-inferiority design, comparing the effect of iron supplementation versus a gluten-free diet alone on ferritin levels.
Gluten-free diet
Participants in the control group will follow a strict gluten-free diet, the standard-of-care treatment for celiac disease. No iron supplementation will be given. Compliance will be monitored through self-reported adherence and TTG antibody levels at follow-up.
Eligibility Criteria
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Inclusion Criteria
* Newly diagnosed with celiac disease (based on ESPGHAN guidelines)
* Ferritin levels below 15 ng/dL
* Normal hemoglobin, MCV, and MCH levels for age and sex
Exclusion Criteria
* Potential celiac disease (positive serology with normal intestinal histology)
* Underlying diseases that may cause anemia (e.g., Inflammatory bowel disease, eosinophilic gastrointestinal disease, certain gastritis types)
* Diseases affecting iron absorption (e.g., Cystic Fibrosis)
* Congenital anemia (e.g., Thalassemia, hereditary spherocytosis)
* Prior iron supplementation (\>14 days oral iron within 2 months or IV iron within 6 months before diagnosis)
18 Months
18 Years
ALL
No
Sponsors
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Schneider Children's Hospital
OTHER
Rambam Hospital, Haifa, Israel
UNKNOWN
Meir Medical Center
OTHER
Assuta Ashdod Hospital
OTHER
Kaplan Medical Center
OTHER
Responsible Party
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Tal Ben-Ami
Head of Pedatric Hematology Unit
Locations
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Assuta Ashdod Medical Center
Ashdod, Israel, Israel
Rambam Medical Center
Haifa, Israel, Israel
Meir Medical Center
Kfar Saba, Israel, Israel
Schneider Children's Medical Center
Petah Tikva, Israel, Israel
Kaplan Medical Center
Rehovot, Israel, Israel
Countries
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Central Contacts
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Yael Zeitek, PhD
Role: CONTACT
Facility Contacts
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References
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Ben-Ami T, Trotskovsky A, Topf-Olivestone C, Kori M. Iron deficiency without anemia in children with newly diagnosed celiac disease: 1-year follow-up of ferritin levels, with and without iron supplementation. Eur J Pediatr. 2024 Nov;183(11):4705-4710. doi: 10.1007/s00431-024-05721-1. Epub 2024 Aug 27.
Other Identifiers
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KMC-25-0038
Identifier Type: -
Identifier Source: org_study_id
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