Iron Deficiency Without Anemia in Children With Newly Diagnosed Celiac Disease: A Randomized, Open-Label, Controlled Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 150
- Locations
- 5
- Primary Endpoint
- Change in ferritin levels from baseline to 12 months
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Months to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Intervention group
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
Intervention: Iron (III) Hydroxide Polymaltose (50 mg/5 mL) (Drug)
Intervention group
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
Intervention: Gluten-free diet (Other)
Control group
Gluten-free diet
Intervention: Gluten-free diet (Other)
Outcomes
Primary Outcomes
Change in ferritin levels from baseline to 12 months
Time Frame: At baseline (Day 0), 4 months (±1 month), and 12 months (±1 month) after enrollment
This study measures the change in serum ferritin levels in children with newly diagnosed celiac disease and iron deficiency (without anemia) over a 12-month period. Participants will have their ferritin levels assessed at: Baseline (At Diagnosis) 4 Months 12 Months The primary objective is to determine whether the gluten-free diet alone leads to a ferritin level increase that is non-inferior to the increase seen in children receiving oral iron supplementation in addition to a gluten-free diet.
Secondary Outcomes
- Change in Anti-TTG antibody levels(At baseline (Day 0), 4 months (±1 month), and 12 months (±1 month) after enrollment)
- Change in BMI(At baseline (Day 0), 4 months (±1 month), and 12 months (±1 month) after enrollment)
- Self-reported adherence to gluten-free diet(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)
- Adherence to iron supplementation (intervention group only)(Weekly up to 3 months after enrollment)
- Percentage of participants with ferritin ≥15 ng/mL at 12 Months(12 months (±1 month) after enrollment)
- Change in weight(At baseline (Day 0), 4 months (±1 month), and 12 months (±1 month) after enrollment)
- Gastrointestinal symptoms evaluation(Weekly (Intervention Group Only up to 12 weeks)), 4 Months (±1 month), 12 Months (±1 month) after enrollment)
- Evaluation of hemoglobin levels for anemia(4 months (±1 month), 12 months (±1 month) after enrollment)
- Association of H. pylori at diagnosis with GI symptoms(At baseline (Day 0), 4 months (±1 month), and 12 months (±1 month) after enrollment)
- Change in height(At baseline (Day 0), 4 months (±1 month), and 12 months (±1 month) after enrollment)
- Association of H. pylori at diagnosis with Ferritin levels over time(At baseline (Day 0), 4 months (±1 month), and 12 months (±1 month) after enrollment)
- Change in anti-TTG IgA antibody levels as an indicator of adherence to gluten-free diet(At 4 months (±1 month) and 12 months (±1 month) after enrollment)
Investigators
Tal Ben-Ami
Head of Pedatric Hematology Unit
Kaplan Medical Center