Clinical trial NCT06921343: Iron Deficiency in Pediatric Celiac Disease: Diet vs. Iron Supplementation Trial
Official title: Iron Deficiency Without Anemia in Children With Newly Diagnosed Celiac Disease: A Randomized, Open-Label, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Celiac Disease in Children
Iron Deficiency
Keywords: Celiac disease
Pediatric celiac disease
Iron deficiency
Ferritin levels
Gluten-free diet
Iron supplementation
Lead sponsor: Kaplan Medical Center
Sponsor class: OTHER
Collaborators: name: Schneider Children's Hospital
name: Rambam Hospital, Haifa, Israel
name: Meir Medical Center
name: Assuta Ashdod Hospital
First posted: 2025-04-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 outcomes:
measure: Change in ferritin levels from baseline to 12 months
timeFrame: At baseline (Day 0), 4 months (±1 month), and 12 months (±1 month) after enrollment
Secondary outcomes:
measure: Change in Anti-TTG antibody levels
timeFrame: At baseline (Day 0), 4 months (±1 month), and 12 months (±1 month) after enrollment
measure: Self-reported adherence to gluten-free diet
timeFrame: Weekly (for intervention group up to 12 weeks), monthly (via phone, control arm, up to 12 weeks)), 4 months (±1 month), and 12 months (±1 month) after enrollment
measure: Adherence to iron supplementation (intervention group only)
timeFrame: Weekly up to 3 months after enrollment
measure: Percentage of participants with ferritin ≥15 ng/mL at 12 Months
timeFrame: 12 months (±1 month) after enrollment
measure: Change in weight
timeFrame: At baseline (Day 0), 4 months (±1 month), and 12 months (±1 month) after enrollment
measure: Gastrointestinal symptoms evaluation
timeFrame: Weekly (Intervention Group Only up to 12 weeks)), 4 Months (±1 month), 12 Months (±1 month) after enrollment
measure: Evaluation of hemoglobin levels for anemia
timeFrame: 4 months (±1 month), 12 months (±1 month) after enrollment
measure: Association of H. pylori at diagnosis with GI symptoms
timeFrame: At baseline (Day 0), 4 months (±1 month), and 12 months (±1 month) after enrollment
measure: Change in height
timeFrame: At baseline (Day 0), 4 months (±1 month), and 12 months (±1 month) after enrollment
measure: Change in BMI
timeFrame: At baseline (Day 0), 4 months (±1 month), and 12 months (±1 month) after enrollment
measure: Association of H. pylori at diagnosis with Ferritin levels over time
timeFrame: At baseline (Day 0), 4 months (±1 month), and 12 months (±1 month) after enrollment
measure: Change in anti-TTG IgA antibody levels as an indicator of adherence to gluten-free diet
timeFrame: At 4 months (±1 month) and 12 months (±1 month) after enrollment
Other outcomes:
Locations:
city: Ashdod
country: Israel
facility: Assuta Ashdod Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Petah-Tikva
country: Israel
facility: Schneider Children's Medical Center
city: Rehovot
country: Israel
facility: Kaplan Medical Center
Study officials:
References:
citation: Ben-Ami T, Trotskovsky A, Topf-Olivestone C, Kori M. Iron deficiency without anemia in children with newly diagnosed celiac disease: 1-year follow-up of ferritin levels, with and without iron supplementation. Eur J Pediatr. 2024 Nov;183(11):4705-4710. doi: 10.1007/s00431-024-05721-1. Epub 2024 Aug 27.