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Effectiveness and Impact on the Quality of Life of Ketogenic Diet in Pediatric Patients
RECRUITINGSponsored by Danone Nutricia SpA Società Benefit
Actively Recruiting
SponsorDanone Nutricia SpA Società Benefit
Started2022-03-01
Est. completion2025-12-31
Eligibility
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06309251
Summary
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
Eligibility
Healthy volunteers accepted
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Conditions5
Autism Spectrum DisorderBrain Tumor, PediatricCancerChronic MigraineDrug-resistant Epilepsy
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Actively Recruiting
SponsorDanone Nutricia SpA Società Benefit
Started2022-03-01
Est. completion2025-12-31
Eligibility
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06309251