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RECRUITING
NCT06309251

Effectiveness and Impact on the Quality of Life of Ketogenic Diet in Pediatric Patients

Sponsor: Danone Nutricia SpA Società Benefit

View on ClinicalTrials.gov

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

Official title: Clinical and Nutritional Effectiveness and Impact on the Quality of Life of the Ketogenic Diet in Pediatric Patients With Neurological, Genetic or Metabolic Disorders: a Multicenter Prospective Observational Study

Key Details

Gender

All

Age Range

Any - 18 Years

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2022-03-01

Completion Date

2026-12-31

Last Updated

2025-09-03

Healthy Volunteers

No

Interventions

OTHER

ketogenic diet (as per clinical practice)

Patients recruited receive a ketogenic diet. The prescription, the type of KD protocol and the route of administration will depend, essentially, on the patient's ability and willingness to feed spontaneously and independently, as well as on compliance with the therapies set and the severity of the clinical conditions.

Locations (3)

ASST Fatebenefratelli Sacco (PO "V. Buzzi")

Milan, MI, Italy

Fondazione "Istituto Neurologico Nazionale C. Mondino"

Pavia, PV, Italy

Ospedale Pediatrico Bambino Gesù

Roma, RM, Italy