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

Launched by KAPLAN MEDICAL CENTER · Apr 3, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring the best way to help children who have celiac disease and are also low in iron. Celiac disease can affect how well the body absorbs nutrients, and many children with this condition struggle with low iron levels. The study will involve children aged 18 months to 18 years who have recently been diagnosed with celiac disease and have low iron stores but normal hemoglobin levels. Participants will be randomly assigned to one of two groups: one group will follow a gluten-free diet without any additional iron supplements, while the other group will follow the same diet but will also take iron supplements.

Over the course of a year, researchers will compare the iron levels in both groups to see if the iron supplements make a big difference beyond just the diet. They will also monitor any side effects from the supplements, like stomach discomfort. This study is important because it will help doctors figure out the safest and most effective ways to treat iron deficiency in children with celiac disease. To join the study, children must meet specific guidelines, including being newly diagnosed with celiac disease and having low iron levels, but they should not have any other conditions that could affect their iron absorption.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Children aged 18 months to 18 years
• • 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:
• • IgA deficiency preventing TTG antibody monitoring
• • 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)