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Iron Deficiency Without Anemia in Children With Newly Diagnosed Celiac Disease: A Randomized, Open-Label, Controlled Trial.
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.
Details
| Lead sponsor | Kaplan Medical Center |
|---|---|
| Phase | NA |
| Status | NOT_YET_RECRUITING |
| Enrolment | 150 |
| Start date | 2025-04 |
| Completion | 2028-12 |
Conditions
- Celiac Disease in Children
- Iron Deficiency
Interventions
- Iron (III) Hydroxide Polymaltose (50 mg/5 mL)
- Gluten-free diet
Primary outcomes
- Change in ferritin levels from baseline to 12 months — At baseline (Day 0), 4 months (±1 month), and 12 months (±1 month) after enrollment
This study measures the change in serum ferritin levels in children with newly diagnosed celiac disease and iron deficiency (without anemia) over a 12-month period. Participants will have their ferritin levels assessed at: Baseline (At Diagnosis) 4 Months 12 Months The primary objective is to determine whether the gluten-free diet alone leads to a ferritin level increase that is non-inferior to the increase seen in children receiving oral iron supplementation in addition to a gluten-free diet.
Countries
Israel