Iron Deficiency in Pediatric Celiac Disease: Diet vs. Iron Supplementation Trial (NCT06921343) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Iron Deficiency in Pediatric Celiac Disease: Diet vs. Iron Supplementation Trial
Israel150 participantsStarted 2025-04
Plain-language 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.
Who can participate
Age range
18 Months – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in ferritin levels from baseline to 12 months
Timeframe: At baseline (Day 0), 4 months (±1 month), and 12 months (±1 month) after enrollment