[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539854":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":26,"responsibleParty":77,"collaborators":10,"id":79,"slug":10,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":10,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":10,"maxAge":86,"enrollmentInfo":87,"targetDuration":10,"studyType":90,"phases":10,"briefSummary":91,"conditions":92,"keywords":10,"overallStatus":29,"whyStopped":10,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Danone Nutricia SpA Società Benefit","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients requiring KD",null,"Pediatric patients with any disease which require a ketogenic diet (KD), i.e. metabolic or genetic disorder or neurological (congenital and acquired) diseases",[13],"Other: ketogenic diet (as per clinical practice)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"OTHER","ketogenic diet (as per clinical practice)","Patients recruited receive a ketogenic diet. The prescription, the type of KD protocol and the route of administration will depend, essentially, on the patient's ability and willingness to feed spontaneously and independently, as well as on compliance with the therapies set and the severity of the clinical conditions.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Antonella Diamanti, MD","CONTACT","+39 06 6859 2189","antonella.diamanti@opbg.net",[27,48,65],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"ASST Fatebenefratelli Sacco (PO \"V. Buzzi\")","RECRUITING","Milan","MI","20154","Italy","IT",{"type":36,"coordinates":37},"Point",[38,39],9.18951,45.46427,{"lat":39,"lon":38},[42,45],{"name":43,"role":23,"phone":10,"phoneExt":10,"email":44},"Sara Olivotto, MD","sara.olivotto@asst-fbf-sacco.it",{"name":46,"role":23,"phone":10,"phoneExt":10,"email":47},"Roberto Previtali, MD","roberto.previtali@unimi.it",{"facility":49,"status":29,"city":50,"state":51,"zip":52,"country":33,"countryCode":34,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"Fondazione \"Istituto Neurologico Nazionale C. Mondino\"","Pavia","PV","27100",{"type":36,"coordinates":54},[55,56],9.15917,45.19205,{"lat":56,"lon":55},[59,62],{"name":60,"role":23,"phone":10,"phoneExt":10,"email":61},"Valentina De Giorgis, MD","valentina.degiorgis@mondino.it",{"name":63,"role":23,"phone":10,"phoneExt":10,"email":64},"Carlo Alberto Quaranta, MD","carloalberto.quaranta01@universitadipavia.it",{"facility":66,"status":29,"city":67,"state":68,"zip":69,"country":33,"countryCode":34,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Ospedale Pediatrico Bambino Gesù","Roma","RM","00165",{"type":36,"coordinates":71},[72,73],11.10642,44.99364,{"lat":73,"lon":72},[76],{"name":22,"role":23,"phone":10,"phoneExt":10,"email":25},{"type":78,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100539854",false,"NCT06309251","Effectiveness and Impact on the Quality of Life of Ketogenic Diet in Pediatric Patients","Clinical and Nutritional Effectiveness and Impact on the Quality of Life of the Ketogenic Diet in Pediatric Patients With Neurological, Genetic or Metabolic Disorders: a Multicenter Prospective Observational Study","Inclusion Criteria:\n\n* Pediatric patients (aged \\\u003C 18 years) with drug-resistant epilepsy (fail to achieve (and maintain) seizure freedom with adequate trials of two or more antiseizure medications) or genetic, metabolic, neurological (congenital and acquired) diseases treated with ketogenic diet\n* Pediatric patients (aged \\\u003C 18 years) with metabolic, genetic or neurological (congenital and acquired) diseases (not necessarily associated with drug-resistant epilepsy) treated with ketogenic diet; this includes the new KD indications or the administration of KD in the ICU for status epilepticus.\n\nExclusion Criteria:\n\n* Patients affected by beta-oxidation cycle disorders, systemic primary carnitine deficiency, primary dyslipidemia, pyruvate carboxylase deficiency, porphyria, mitochondrial disease, defects in ketone body metabolism (ketogenesis or ketolysis), defect in gluconeogenesis.\n* Children with type 1 diabetes\n* Parents (or caregivers) unable to guarantee adherence to the","ALL","18 Years",{"count":88,"type":89},100,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn about the clinical and nutritional effectiveness of ketogenic diet (KD) in pediatric patients with genetic, neurological or metabolic conditions requiring KD.\n\nThe main question\\[s\\] it aims to answer are:\n\n* does KD support adequate growth?\n* does KD improve clinical symptoms?\n* how does KD impact quality of life? Participants will be followed up as per clinical practice",[93,94,95,96],"Drug Resistant Epilepsy","Autism Spectrum Disorder","Chronic Migraine","Brain Tumor, Pediatric","2025-08-26",{"date":99,"type":100},"2025-09-03","ACTUAL",{"date":102,"type":100},"2022-03-01",{"date":104,"type":89},"2026-12-31",{"name":5,"class":6},3]