Celiac Disease in ChildrenNCT06921343
Iron Deficiency in Pediatric Celiac Disease: Diet vs. Iron Supplementation Trial
A study testing Iron (III) Hydroxide Polymaltose (50 mg/5 mL) and Gluten-free diet in people with Celiac Disease in Children and Iron Deficiency, run by Kaplan Medical Center at 5 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 months to 18 years
- Conditions the study is for
- Celiac Disease in Children, Iron Deficiency
- What is being tested?
- Iron (III) Hydroxide Polymaltose (50 mg/5 mL) and Gluten-free diet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 5 sitesIsrael
- Study dates
- Apr 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Yael Zeitek, PhD contact
5 sites in 1 country
Israel5 sites
Assuta Ashdod Medical Center
Ashdod, Israel, 7747629
Chani Topf-Olivestone, MD, 972 54-463-8297, chaniolive@gmail.com
Chani Topf-Olivestone, MD
Rambam Medical Center
Haifa, Israel, 3109601
Ron Shaoul, MD, +972-50-2063333, shaoul_r@012.net.il
Ron Shaoul, MD
Meir Medical Center
Kfar Saba, Israel, 4428163
Eyal Zifman, MD, +972-54-5740004, drzifman@gmail.com
Eyal Zifman, MD
Schneider Children's Medical Center
Petah Tikva, Israel, 4920235
Anat Guz, MD, +972544228113, anatguz@gmail.com
Anat Guz, MD
Kaplan Medical Center
Rehovot, Israel, 7661041
Tal Ben Ami, MD, 0507414922, tal.ben.ami11@gmail.com
Yael Zeitak, PhD, +972-52-627-4987, yaelze4@clalit.org.il
About this study
Official title: Iron Deficiency Without Anemia in Children With Newly Diagnosed Celiac Disease: A Randomized, Open-Label, Controlled 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:
Read more
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.
Read the 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.
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.
- Conditions
- Celiac Disease in Children, Iron Deficiency
- Being tested
- Iron (III) Hydroxide Polymaltose (50 mg/5 mL), Gluten-free diet
- Keywords
- Celiac disease, Pediatric celiac disease, Iron deficiency, Ferritin levels, Gluten-free diet, Iron supplementation
- Medical subject headings
- Iron Deficiencies, Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 dietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Iron (III) Hydroxide Polymaltose (50 mg/5 mL); Other: Gluten-free diet |
| Control group | Active comparator | Gluten-free diet Receives: Other: Gluten-free diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline (Day 0), 4 months (±1 month), and 12 months (±1 month) after enrollment
Secondary outcomes (12)
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.
Measured: 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)
Measured: 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
Measured: 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.
Measured: 12 months (±1 month) after enrollment
Change in weight
Evaluates weight patterns in children with celiac disease by measuring:
Weight (kg)
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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
Measured: At 4 months (±1 month) and 12 months (±1 month) after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study startApr 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Celiac Disease in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaplan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Schneider Children's Hospital, Rambam Health Care Campus, Meir Medical Center, Assuta Ashdod Hospital
- Responsible party
- Principal investigator, Tal Ben-Ami, Kaplan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921343
- Sponsor's protocol ID
- KMC-25-0038
- Status last verified
- Apr 2025
- First submitted
- 25 Mar 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 39190044
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Deficiency Without Anemia in Children With Newly Diagnosed Celiac Disease: A Randomized, Open-Label, Controlled Trial.
- ClinicalTrials.gov ID
- NCT06921343
- Acronym / sponsor ID
- KMC-25-0038
- Conditions
- Celiac Disease in Children, Iron Deficiency
- Keywords
- Celiac disease, Pediatric celiac disease, Iron deficiency, Ferritin levels, Gluten-free diet, Iron supplementation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Kaplan Medical CenterUniversity, hospital or other
- Collaborators
- Schneider Children's Hospital, Rambam Health Care Campus, Meir Medical Center, Assuta Ashdod Hospital
- Study start
- Apr 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Iron (III) Hydroxide Polymaltose (50 mg/5 mL), Other: Gluten-free dietGluten-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 |
| Control group | Active comparator | Other: Gluten-free dietGluten-free diet |
Who may qualify
- Ages
- 18 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron (III) Hydroxide Polymaltose (50 mg/5 mL)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. | Drug | Intervention group |
| Gluten-free dietParticipants 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. | Other | Control group, Intervention group |
Primary outcome
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.
12 secondary outcomes
Change in Anti-TTG antibody levels
Time frame: At baseline (Day 0), 4 months (±1 month), and 12 months (±1 month) after enrollment
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
Adherence to iron supplementation (intervention group only)
Time frame: Weekly up to 3 months after enrollment
Percentage of participants with ferritin ≥15 ng/mL at 12 Months
Time frame: 12 months (±1 month) after enrollment
Change in weight
Time frame: At baseline (Day 0), 4 months (±1 month), and 12 months (±1 month) after enrollment
Gastrointestinal symptoms evaluation
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
Time frame: 4 months (±1 month), 12 months (±1 month) after enrollment
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
Change in height
Time frame: At baseline (Day 0), 4 months (±1 month), and 12 months (±1 month) after enrollment
Change in BMI
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
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
Time frame: At 4 months (±1 month) and 12 months (±1 month) after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Background: PubMed 39190044Ben-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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yael Zeitek, PhD contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron (III) Hydroxide Polymaltose (50 mg/5 mL) and Gluten-free diet in people with Celiac Disease in Children and Iron Deficiency, run by Kaplan Medical Center at 5 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tal Ben-Ami, M.D (+972-8-9441566, tal.ben.ami11@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06921343, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.