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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-18
SponsorKaplan Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Iron (III) Hydroxide Polymaltose (50 mg/5 mL)
  • Gluten-free diet

Treatment groups

150 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Kaplan Medical Center

Lead sponsor

Schneider Children's Hospital

Collaborator

Rambam Health Care Campus

Collaborator

Meir Medical Center

Collaborator

Assuta Ashdod Hospital

Collaborator