Effectiveness and Impact on the Quality of Life of Ketogenic Diet in Pediatric Patients
Recruiting · NCT06309251 · Observational (researchers observe without assigning treatment) · Lead sponsor: Danone Nutricia SpA Società Benefit
View the official record on ClinicalTrials.gov →Interventions studied
ketogenic diet (as per clinical practice)
What this trial is about
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
Who can take part
Age range
Up to 18 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
6 locations listed.
- ASST Fatebenefratelli Sacco (PO "V. Buzzi") - Milan, MI, Italy
- ASST Fatebenefratelli Sacco (PO "V. Buzzi") - Milan, MI, Italy
- Fondazione "Istituto Neurologico Nazionale C. Mondino" - Pavia, PV, Italy
- Fondazione "Istituto Neurologico Nazionale C. Mondino" - Pavia, PV, Italy
- Ospedale Pediatrico Bambino Gesù - Roma, RM, Italy
- Ospedale Pediatrico Bambino Gesù - Roma, RM, Italy