Status:
NOT_YET_RECRUITING
Iron Deficiency in Pediatric Celiac Disease: Diet vs. Iron Supplementation Trial
Lead Sponsor:
Kaplan Medical Center
Collaborating Sponsors:
Schneider Children's Hospital
Rambam Hospital, Haifa, Israel
Conditions:
Celiac Disease in Children
Iron Deficiency
Eligibility:
All Genders
18-18 years
Phase:
NA
Brief 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 anemi...
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 def...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06921343
Start Date
April 1 2025
End Date
December 1 2028
Last Update
April 10 2025
Active Locations (5)
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1
Assuta Ashdod Medical Center
Ashdod, Israel, Israel, 7747629
2
Rambam Medical Center
Haifa, Israel, Israel, 3109601
3
Meir Medical Center
Kfar Saba, Israel, Israel, 4428163
4
Schneider Children's Medical Center
Petah Tikva, Israel, Israel, 4920235