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

NCT06921343 | Not Yet Recruiting

• 1 other identifier: KMC-25-0038
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 5

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.

Conditions

Celiac Disease in Children; Iron Deficiency

Keywords

Celiac disease; Pediatric celiac disease; Iron deficiency; Ferritin levels; Gluten-free diet; Iron supplementation

Outcome Measures

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.

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

Secondary Outcomes (12)

• Change in Anti-TTG antibody levels

  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

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Drug: Iron (III) Hydroxide Polymaltose (50 mg/5 mL); Other: Gluten-free diet

Control group

ACTIVE COMPARATOR

Gluten-free diet

Other: Gluten-free diet

Interventions

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.

Intervention group

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.

Control group; Intervention group

Eligibility Criteria

• Age: 18 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kaplan Medical Center: lead
• Schneider Children's Hospital: collaborator
• Rambam Hospital, Haifa, Israel: collaborator
• Meir Medical Center: collaborator
• Assuta Ashdod Hospital: collaborator

Study Sites (5)

Assuta Ashdod Medical Center

Ashdod, Israel, 7747629, Israel

Location

Rambam Medical Center

Haifa, Israel, 3109601, Israel

Location

Meir Medical Center

Kfar Saba, Israel, 4428163, Israel

Location

Schneider Children's Medical Center

Petah Tikva, Israel, 4920235, Israel

Location

Kaplan Medical Center

Rehovot, Israel, 7661041, Israel

Location

Related Publications (1)

• 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.

  PMID: 39190044 BACKGROUND

MeSH Terms

Conditions

Iron Deficiencies; Celiac Disease

Interventions

Iron; Diet, Gluten-Free

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Tal Ben-Ami, M.D

CONTACT

+972-8-9441566; tal.ben.ami11@gmail.com

Yael Zeitek, PhD

CONTACT

+972-52-627-4987

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pedatric Hematology Unit

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 10, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (5)