Clinical Trial

Iron Deficiency in Pediatric Celiac Disease: Diet vs. Iron Supplementation Trial

Not Yet Recruiting
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Summary
This study aims to understand how to best manage iron deficiency in children newly diagnosed with celiac disease. Many children with celiac disease have low iron levels, even if they do not have anemia. While some doctors recommend iron supplements, others believe that simply following a gluten-free diet may be enough to restore iron levels naturally. 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.
Trial Details
NCT Number NCT06921343
Lead Sponsor Kaplan Medical Center
Collaborators: Schneider Children's Hospital, Rambam Health Care Campus, Meir Medical Center, Assuta Ashdod Hospital
Conditions Celiac Disease in Children, Iron Deficiency
Enrollment 150 participants
Start Date 2025-04
Primary Completion 2027-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2025-04-10