NCT06921343

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

Iron Deficiency Without Anemia in Children With Newly Diagnosed Celiac Disease: A Randomized, Open-Label, Controlled Trial.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Kaplan Medical Center · Academic / Other
• Sex: All
• Age: 18 Months – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, randomized, controlled, open-label, non-inferiority trial designed to evaluate the necessity of iron supplementation in children newly diagnosed with celiac disease and iron deficiency without anemia. The study will compare two treatment strategies: 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

• Celiac Disease in Children
• Iron Deficiency

Interventions

Type	Name	Description
DRUG	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.
OTHER	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.

Timeline

• Start date: 2025-04-01
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2025-04-10
• Last updated: 2025-04-10

Locations

5 sites across 1 country: Israel