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NCT Number: NCT06921343

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

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Key information

Conditions

Celiac Disease in Children Celiac Disease Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Iron Deficiencies Iron Deficiency Iron Metabolism Disorders Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assuta Ashdod Medical Center, Ashdod, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

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.

Primary outcomes

  1. 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

  1. Change in Anti-TTG antibody levels

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

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

  2. Self-reported adherence to gluten-free diet

    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

    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)

  3. Adherence to iron supplementation (intervention group only)

    Time frame: Weekly up to 3 months after enrollment

    Measures compliance with iron supplementation in the experimental group.

    Assessment Methods:

    Parental reporting via weekly logs Pharmacy refill records

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

    Time frame: 12 months (±1 month) after enrollment

    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.

  5. Change in weight

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

    Evaluates weight patterns in children with celiac disease by measuring:

    Weight (kg)

  6. Gastrointestinal symptoms evaluation

    Time frame: Weekly (Intervention Group Only up to 12 weeks)), 4 Months (±1 month), 12 Months (±1 month) after enrollment

    Symptoms recorded in a standardized questionnaire using units on a scale (0-4)

  7. Evaluation of hemoglobin levels for anemia

    Time frame: 4 months (±1 month), 12 months (±1 month) after enrollment

    Monitor hemoglobin levels in both study groups to identify participants who develop anemia, which would necessitate early withdrawal from the study and initiation of iron treatment.

    Hemoglobin blood tests will be conducted at 4 months and 12 months for all participants.

    If a participant develops hemoglobin levels below age-adjusted reference values, the study protocol requires discontinuation from the trial and initiation of iron therapy as per clinical guidelines.

    The frequency of anemia-related study withdrawals will be documented and analyzed.

  8. Association of H. pylori at diagnosis with GI symptoms

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

    Evaluate whether children with H. pylori-positive gastric biopsies at the time of celiac disease diagnosis experience a higher frequency or severity of gastrointestinal (GI) symptoms during follow-up compared to H. pylori-negative participants.

    GI symptoms will be assessed using standardized questionnaires with units on a scale (0-4)

  9. Change in height

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

    Evaluates height patterns in children with celiac disease by measuring:

    height (cm)

  10. Change in BMI

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

    Evaluates BMI patterns in children with celiac disease. Weight and height will be combined to report BMI in kg/m^2

  11. Association of H. pylori at diagnosis with Ferritin levels over time

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

    Assess whether the presence of H. pylori in gastric biopsies at the time of celiac disease diagnosis is associated with the trajectory of ferritin (ng/ml) levels from baseline through 12 months, in both the iron supplementation and diet-only groups.

  12. Change in anti-TTG IgA antibody levels as an indicator of adherence to gluten-free diet

    Time frame: At 4 months (±1 month) and 12 months (±1 month) after enrollment

    Anti-TTG IgA levels in U/mL

Study contacts

Contact information is provided by the study sponsor or research team.

Tal Ben-Ami, M.D

CONTACT

[email protected]

+972-8-9441566

Yael Zeitek, PhD

CONTACT

+972-52-627-4987

Sponsors and collaborators

Lead sponsor

Kaplan Medical Center

Other

Collaborators

  • Assuta Ashdod Hospital
  • Meir Medical Center
  • Rambam Health Care Campus
  • Schneider Children's Hospital

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Apr 10, 2025
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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