Health Trials

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • ketogenic diet (as per clinical practice)

Treatment groups

100 Participants
are divided into 1 treatment group

Locations

3
ASST Fatebenefratelli Sacco (PO "V. Buzzi")20154, MilanMI, Italy
Fondazione "Istituto Neurologico Nazionale C. Mondino"27100, PaviaPV, Italy
Ospedale Pediatrico Bambino Gesù00165, RomaRM, Italy

Sponsors and collaborators

Danone Nutricia SpA Società Benefit

Lead sponsor

Source ClinicalTrials.gov