Iron Deficiency in Pediatric Celiac Disease: Diet vs. Iron Supplementation Trial
Key facts
- Who runs it
- Kaplan Medical Center
- Where
- Ashdod, Haifa, Kfar Saba, Petah Tikva, and Rehovot, IsraelSee the 5 sites
- Trial code
- Status
- Not yet recruiting
- People taking part
- 150 people, planned
- Started
- Apr 2025
- Expected to end
- Dec 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Iron (III) Hydroxide Polymaltose (50 mg/5 mL)
- Gluten-free diet
- Record updated
- 10 April 2025
Who can take part
- Age
- 18 months to 18 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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
Who cannot take part
- IgA deficiency preventing TTG antibody monitoring
- Prior iron supplementation (>14 days oral iron within 2 months or IV iron within 6 months before diagnosis)
- 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)
Where in Israel
- Assuta Ashdod Medical CenterAshdod, IsraelContact: Chani Topf-Olivestone, MDNo longer taking part
- Rambam Medical CenterHaifa, IsraelContact: Ron Shaoul, MDNo longer taking part
- Meir Medical CenterKfar Saba, IsraelContact: Eyal Zifman, MDNo longer taking part
- Schneider Children's Medical CenterPetah Tikva, IsraelContact: Anat Guz, MDNo longer taking part
- Kaplan Medical CenterRehovot, IsraelContact: Tal Ben Ami, MDNo longer taking part
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Intervention groupTreatment being tested
Gluten-free diet + Oral Iron Supplementation Iron (III) Hydroxide Polymaltose (50 mg/5 mL) at a single dose of 6 mg/kg/day, maximum 100 mg/day, for 3 months
Treatment: Iron (III) Hydroxide Polymaltose (50 mg/5 mL) and Gluten-free diet
- Control groupExisting treatment, for comparison
Gluten-free diet
Treatment: Gluten-free diet
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Iron Deficiency Without Anemia in Children With Newly Diagnosed Celiac Disease: A Randomized, Open-Label, Controlled Trial.
- Record updated
- 10 April 2025