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

Kaplan Medical Center

Status: Not yet enrolling

Conditions: Iron Deficiency; Celiac Disease in Children

Treatments: Other: Gluten-free diet; Drug: Iron (III) Hydroxide Polymaltose (50 mg/5 mL)

Study type: Interventional

Funder types: Other

Identifiers

NCT06921343

KMC-25-0038

Details and patient eligibility

About

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.

Full 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 deficiency without anemia. The study will compare two treatment strategies:

Gluten-Free Diet Alone Gluten-Free Diet + Iron Supplementation The primary objective is to determine whether a gluten-free diet alone is sufficient to restore ferritin levels or if iron supplementation provides a significant additional benefit.

Study Design & Methods Eligible participants will be randomly assigned to one of the two treatment groups.

Ferritin levels will be monitored at baseline, 4 months, and 12 months to assess improvements.

The study will also evaluate patient adherence to a gluten-free diet and iron supplementation, quality of life, as well as the incidence of gastrointestinal side effects related to iron supplement use.

This study is expected to provide evidence-based guidance for the management of iron deficiency in pediatric celiac disease, addressing a gap in current clinical recommendations.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 months to 18 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Intervention group

Experimental group

Description:

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:

Drug: Iron (III) Hydroxide Polymaltose (50 mg/5 mL)

Other: Gluten-free diet

Control group

Active Comparator group

Description:

Gluten-free diet

Treatment:

Other: Gluten-free diet