Under construction – not a live service
Sign in
Not yet recruitingNo phase

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

Key facts

Who runs it
Kaplan Medical Center
Where
Israel5 sites in 1 countryChoose a country to see its 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)

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data 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