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

ClinicalTrials.gov ID

NCT06921343

Lead Sponsor

Kaplan Medical CenterOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

150Estimated

Last Update Posted

Apr 10, 2025Actual

Start Date

Apr 2025Estimated

Primary Completion Date

Dec 2027Estimated

Completion Date

Dec 2028Estimated

Official Title

Iron Deficiency Without Anemia in Children With Newly Diagnosed Celiac Disease: A Randomized, Open-Label, Controlled Trial.

Brief 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.

Detailed 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.

• Celiac Disease in Children
• Iron Deficiency

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

Ages Eligible for Study

Child (0-17)Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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)

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Kaplan Medical CenterOTHER

Collaborators

Schneider Children's HospitalOTHER

Rambam Health Care CampusOTHER

Meir Medical CenterOTHER

Assuta Ashdod HospitalOTHER

shaoul_r@012.net.il+972-50-2063333

drzifman@gmail.com+972-54-5740004

tal.ben.ami11@gmail.com0507414922

• Efficacy of Oral Sucrosomial Iron Supplementation in Children With Celiac Disease and Iron Deficiency or Anemia

  NCT07563582

  RecruitingInterventionalNot ApplicableUpdated May 4, 2026
• Effects of a Dietary Approach to Iron Deficiency in Premenopausal Women Affected by Celiac Disease

  NCT02949765

  Unknown statusInterventionalNot ApplicableUpdated Mar 14, 2017
• Effect of Intravenous Iron Supplementation on Celiac Disease Remission (IRONCEL)

  NCT05114278

  TerminatedInterventionalPhase 4Updated Jul 9, 2026
• Iron Deficiency and TTG Normalization

  NCT05675280

  CompletedObservationalUpdated Jan 11, 2023
• Celiac Disease and Unexplained Iron Deficiency in a Primary Care Setting

  NCT02036944

  TerminatedObservationalUpdated Apr 5, 2016
• Iron Treatment for Young Children With Non-anemic Iron Deficiency

  NCT01481766

  CompletedInterventionalNot ApplicableUpdated Oct 30, 2025