An interventional study of Iron (III) Hydroxide Polymaltose (50 mg/5 mL) and Gluten-free diet in Celiac Disease in Children and Iron Deficiency, sponsored by Kaplan Medical Center. Not yet recruiting at 5 sites in Israel. Open to participants aged 18 Months to 18 Years. Per ClinicalTrials.gov, last updated 2025-04-10.
Sponsored by Kaplan Medical Center · Not applicable, Interventional, and Treatment
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.
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.
386 studies on the registry are indexed under Iron Deficiencies; 80 are open to participants now.
This study's planned enrollment of 150 is above the median of 99 across 301 interventional studies indexed under Iron Deficiencies.
Browse Iron Deficiencies studies →Kaplan Medical Center is the lead sponsor of 37 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Gluten-free diet
Other: Gluten-free diet
Drug page: Teferrol
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.
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.
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
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
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
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
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
Change in weight
Evaluates weight patterns in children with celiac disease by measuring: Weight (kg)
Time frame: At baseline (Day 0), 4 months (±1 month), and 12 months (±1 month) after enrollment
Gastrointestinal symptoms evaluation
Symptoms recorded in a standardized questionnaire using units on a scale (0-4)
Time frame: Weekly (Intervention Group Only up to 12 weeks)), 4 Months (±1 month), 12 Months (±1 month) after enrollment
Evaluation of hemoglobin levels for anemia
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.
Time frame: 4 months (±1 month), 12 months (±1 month) after enrollment
Association of H. pylori at diagnosis with GI symptoms
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)
Time frame: At baseline (Day 0), 4 months (±1 month), and 12 months (±1 month) after enrollment
Change in height
Evaluates height patterns in children with celiac disease by measuring: height (cm)
Time frame: At baseline (Day 0), 4 months (±1 month), and 12 months (±1 month) after enrollment
Change in BMI
Evaluates BMI patterns in children with celiac disease. Weight and height will be combined to report BMI in kg/m\^2
Time frame: 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
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.
Time frame: 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
Anti-TTG IgA levels in U/mL
Time frame: At 4 months (±1 month) and 12 months (±1 month) after enrollment
Plan to share: No — The study collects sensitive data on pediatric participants. Due to privacy concerns and limitations in obtaining broad consent for future use of individual-level data, IPD will not be shared.
Start is estimated for Apr 2025; primary completion for Dec 2027, 32 months later.
Of 76 non-industry interventional studies with no phase under Iron Deficiencies, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 26. This study's planned 32 months is above that.
Counting every sponsor, half of 88 studies reached it within 10 months; a quarter within 5 and three quarters within 26.
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This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Teferrol
Kaplan Medical Center