[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586896":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":39,"responsibleParty":120,"collaborators":123,"id":131,"slug":132,"hasResults":133,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":26,"eligibilityCriteria":137,"healthyVolunteers":133,"sex":138,"minAge":139,"maxAge":140,"enrollmentInfo":141,"targetDuration":26,"studyType":144,"phases":145,"briefSummary":147,"conditions":148,"keywords":151,"overallStatus":157,"whyStopped":26,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},{"fullName":5,"class":6},"Kaplan Medical Center","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL","Gluten-free diet + Oral Iron Supplementation Iron (III) Hydroxide Polymaltose (50 mg\u002F5 mL) at a single dose of 6 mg\u002Fkg\u002Fday, maximum 100 mg\u002Fday, for 3 months",[13,14],"Drug: Iron (III) Hydroxide Polymaltose (50 mg\u002F5 mL)","Other: Gluten-free diet",{"label":16,"type":17,"description":18,"interventionNames":19},"Control group","ACTIVE_COMPARATOR","Gluten-free diet",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Iron (III) Hydroxide Polymaltose (50 mg\u002F5 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\u002F5 mL) at a dosage of 6 mg\u002Fkg\u002Fday, up to a maximum of 100 mg\u002Fday, for 3 months.\n\nThe iron supplement will be given once daily, preferably on an empty stomach or with vitamin C-containing foods to enhance absorption. Parents\u002Fcaregivers will be instructed on proper administration, and adherence will be monitored through weekly self-reported intake logs and pharmacy dispensing records.\n\nThis intervention is specifically targeted at children with newly diagnosed celiac disease and iron deficiency without anemia.\n\nThe study follows a non-inferiority design, comparing the effect of iron supplementation versus a gluten-free diet alone on ferritin levels.",[9],null,{"type":6,"name":18,"description":28,"armGroupLabels":29,"otherNames":26},"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.",[16,9],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Tal Ben-Ami, M.D","CONTACT","+972-8-9441566","tal.ben.ami11@gmail.com",{"name":37,"role":33,"phone":38,"phoneExt":26,"email":26},"Yael Zeitek, PhD","+972-52-627-4987",[40,59,74,89,104],{"facility":41,"status":26,"city":42,"state":43,"zip":44,"country":43,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Assuta Ashdod Medical Center","Ashdod","Israel","7747629","IL",{"type":47,"coordinates":48},"Point",[49,50],34.64966,31.79213,{"lat":50,"lon":49},[53,57],{"name":54,"role":33,"phone":55,"phoneExt":26,"email":56},"Chani Topf-Olivestone, MD","972 54-463-8297","chaniolive@gmail.com",{"name":54,"role":58,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"facility":60,"status":26,"city":61,"state":43,"zip":62,"country":43,"countryCode":45,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Rambam Medical Center","Haifa","3109601",{"type":47,"coordinates":64},[65,66],34.99928,32.81303,{"lat":66,"lon":65},[69,73],{"name":70,"role":33,"phone":71,"phoneExt":26,"email":72},"Ron Shaoul, MD","+972-50-2063333","shaoul_r@012.net.il",{"name":70,"role":58,"phone":26,"phoneExt":26,"email":26},{"facility":75,"status":26,"city":76,"state":43,"zip":77,"country":43,"countryCode":45,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Meir Medical Center","Kfar Saba","4428163",{"type":47,"coordinates":79},[80,81],34.90694,32.175,{"lat":81,"lon":80},[84,88],{"name":85,"role":33,"phone":86,"phoneExt":26,"email":87},"Eyal Zifman, MD","+972-54-5740004","drzifman@gmail.com",{"name":85,"role":58,"phone":26,"phoneExt":26,"email":26},{"facility":90,"status":26,"city":91,"state":43,"zip":92,"country":43,"countryCode":45,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Schneider Children's Medical Center","Petah Tikva","4920235",{"type":47,"coordinates":94},[95,96],34.88747,32.08707,{"lat":96,"lon":95},[99,103],{"name":100,"role":33,"phone":101,"phoneExt":26,"email":102},"Anat Guz, MD","+972544228113","anatguz@gmail.com",{"name":100,"role":58,"phone":26,"phoneExt":26,"email":26},{"facility":5,"status":26,"city":105,"state":43,"zip":106,"country":43,"countryCode":45,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Rehovot","7661041",{"type":47,"coordinates":108},[109,110],34.81199,31.89421,{"lat":110,"lon":109},[113,116,119],{"name":114,"role":33,"phone":115,"phoneExt":26,"email":35},"Tal Ben Ami, MD","0507414922",{"name":117,"role":33,"phone":38,"phoneExt":26,"email":118},"Yael Zeitak, PhD","yaelze4@clalit.org.il",{"name":114,"role":58,"phone":26,"phoneExt":26,"email":26},{"type":58,"investigatorFullName":121,"investigatorTitle":122,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Tal Ben-Ami","Head of Pedatric Hematology Unit",[124,126,128,129],{"name":125,"class":6},"Schneider Children's Hospital",{"name":127,"class":6},"Rambam Health Care Campus",{"name":75,"class":6},{"name":130,"class":6},"Assuta Ashdod Hospital","100586896","iron-deficiency-in-pediatric-celiac-disease-diet-vs-iron-supplementation-trial-100586896",false,"NCT06921343","Iron Deficiency in Pediatric Celiac Disease: Diet vs. Iron Supplementation Trial","Iron Deficiency Without Anemia in Children With Newly Diagnosed Celiac Disease: A Randomized, Open-Label, Controlled Trial.","Inclusion Criteria:\n\n* Children aged 18 months to 18 years\n* Newly diagnosed with celiac disease (based on ESPGHAN guidelines)\n* Ferritin levels below 15 ng\u002FdL\n* Normal hemoglobin, MCV, and MCH levels for age and sex\n\nExclusion Criteria:\n\n* IgA deficiency preventing TTG antibody monitoring\n* Potential celiac disease (positive serology with normal intestinal histology)\n* Underlying diseases that may cause anemia (e.g., Inflammatory bowel disease, eosinophilic gastrointestinal disease, certain gastritis types)\n* Diseases affecting iron absorption (e.g., Cystic Fibrosis)\n* Congenital anemia (e.g., Thalassemia, hereditary spherocytosis)\n* Prior iron supplementation (\\>14 days oral iron within 2 months or IV iron within 6 months before diagnosis)","ALL","18 Months","18 Years",{"count":142,"type":143},150,"ESTIMATED","INTERVENTIONAL",[146],"NA","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.\n\nIn this study, children with newly diagnosed celiac disease and low iron levels (but normal hemoglobin) will be randomly assigned to one of two groups:\n\nGluten-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.\n\nThis 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.",[149,150],"Celiac Disease in Children","Iron Deficiency",[152,153,154,155,18,156],"Celiac disease","Pediatric celiac disease","Iron deficiency","Ferritin levels","Iron supplementation","NOT_YET_RECRUITING","2025-04-03",{"date":160,"type":161},"2025-04-10","ACTUAL",{"date":163,"type":143},"2025-04",{"date":165,"type":143},"2028-12",{"name":5,"class":6},5]