Actively Recruiting
Effectiveness and Impact on the Quality of Life of Ketogenic Diet in Pediatric Patients
Led by Danone Nutricia SpA Società Benefit · Updated on 2025-09-03
100
Participants Needed
3
Research Sites
252 weeks
Total Duration
On this page
AI-Summary
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
CONDITIONS
Official Title
Effectiveness and Impact on the Quality of Life of Ketogenic Diet in Pediatric Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pediatric patients under 18 years with drug-resistant epilepsy who have not achieved seizure freedom with two or more antiseizure medications
- Pediatric patients under 18 years with genetic, metabolic, or neurological diseases treated with ketogenic diet, including new indications or ICU use for status epilepticus
You will not qualify if you...
- Patients with beta-oxidation cycle disorders, systemic primary carnitine deficiency, primary dyslipidemia, pyruvate carboxylase deficiency, porphyria, mitochondrial disease, ketone body metabolism defects, or gluconeogenesis defects
- Children with type 1 diabetes
- Parents or caregivers unable to ensure adherence to the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
ASST Fatebenefratelli Sacco (PO "V. Buzzi")
Milan, MI, Italy, 20154
Actively Recruiting
2
Fondazione "Istituto Neurologico Nazionale C. Mondino"
Pavia, PV, Italy, 27100
Actively Recruiting
3
Ospedale Pediatrico Bambino Gesù
Roma, RM, Italy, 00165
Actively Recruiting
Research Team
A
Antonella Diamanti, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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