Health TrialsbyHealthPanel

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

ConditionsCeliac Disease in ChildrenIron Deficiency
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-18
SponsorKaplan Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Iron (III) Hydroxide Polymaltose (50 mg/5 mL)

    Drug

    Participants randomized to the intervention group will receive oral iron supplementation in addition to a gluten-free diet. The specific iron formulation used in this study is Iron (III) Hydroxide Polymaltose (50 mg/5 mL) at a dosage of 6 mg/kg/day, up to a maximum of 100 mg/day, for 3 months. The iron supplement will be given once daily, preferably on an empty stomach or with vitamin C-containing foods to enhance absorption. Parents/caregivers will be instructed on proper administration, and adherence will be monitored through weekly self-reported intake logs and pharmacy dispensing records. This intervention is specifically targeted at children with newly diagnosed celiac disease and iron deficiency without anemia. The study follows a non-inferiority design, comparing the effect of iron supplementation versus a gluten-free diet alone on ferritin levels.

  • Gluten-free diet

    Other intervention

    Participants in the control group will follow a strict gluten-free diet, the standard-of-care treatment for celiac disease. No iron supplementation will be given. Compliance will be monitored through self-reported adherence and TTG antibody levels at follow-up.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 2 interventions
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in ferritin levels from baseline to 12 months

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.

Time frame
At baseline (Day 0), 4 months (±1 month), and 12 months (±1 month) after enrollment

Secondary outcomes

1

Change in Anti-TTG antibody levels

Measures the change in anti-TTG IgA antibody levels, which indicates adherence to a gluten-free diet and mucosal healing in celiac disease.

Time frame
At baseline (Day 0), 4 months (±1 month), and 12 months (±1 month) after enrollment
2

Self-reported adherence to gluten-free diet

Intervention group: Weekly parent-reported logs for 3 months Control group: Monthly telephone questionnaires for 3 months Adherence will be scored based on self-report of unintentional or intentional gluten ingestion on a scale (0-4)

Time frame
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
3

Adherence to iron supplementation (intervention group only)

Measures compliance with iron supplementation in the experimental group. Assessment Methods: Parental reporting via weekly logs Pharmacy refill records

Time frame
Weekly up to 3 months after enrollment
4

Percentage of participants with ferritin ≥15 ng/mL at 12 Months

Determines the proportion of participants who achieve normal iron stores (Ferritin ≥15 ng/mL) at the 12-month follow-up. Helps assess the effectiveness of the interventions in restoring iron stores.

Time frame
12 months (±1 month) after enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kaplan Medical Center

Lead sponsor

Schneider Children's Hospital

Collaborator

Rambam Health Care Campus

Collaborator

Meir Medical Center

Collaborator

Assuta Ashdod Hospital

Collaborator

Source ClinicalTrials.gov

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