Effectiveness and Impact on the Quality of Life of Ketogenic Diet in Pediatric Patients
Recruiting now
Conditions studied: Drug Resistant Epilepsy, Autism Spectrum Disorder, Chronic Migraine, Brain Tumor, Pediatric
In brief
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. The main question\[s\] it aims to answer are: * does KD support adequate growth? * does KD improve clinical symptoms? * how does KD impact quality of life? Participants will be followed up as per clinical practice
Key facts
- Study ID
- NCT06309251
- Run by
- Danone Nutricia SpA Società Benefit
- People needed
- 100
- Starts
- 2022-03-01
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2025-09-03
Who can join
Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Pediatric patients (aged < 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
- Pediatric patients (aged < 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.
You may not qualify if…
- 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.
- Children with type 1 diabetes
- Parents (or caregivers) unable to guarantee adherence to the
Where it is running
- ASST Fatebenefratelli Sacco (PO "V. Buzzi") — Milan, MI, Italy (enrolling)
- Fondazione "Istituto Neurologico Nazionale C. Mondino" — Pavia, PV, Italy (enrolling)
- Ospedale Pediatrico Bambino Gesù — Roma, RM, Italy (enrolling)
Full record on ClinicalTrials.gov
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