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

What this Trial Is About

This research aims to learn about the clinical and nutritional effects of the ketogenic diet (KD) in children with genetic, neurological, or metabolic conditions that require this diet. The study focuses on whether KD supports proper growth, improves clinical symptoms, and impacts quality of life. It involves pediatric patients, including those with drug-resistant epilepsy and other neurological or metabolic diseases, to explore these areas more comprehensively. Participants receive a ketogenic diet as part of their clinical care. The specific prescription, type of KD protocol, and how it is administered depend on each child's ability to feed independently, their willingness, and the severity of their condition. This is an observational study, so treatments are given according to usual clinical practice, and the study follows patients over time to observe outcomes. During the study, participants will be monitored through regular clinical visits that assess nutritional adequacy, such as growth, lipid profiles, vitamin intake, and bone mineral density. Quality of life will be evaluated using parent questionnaires. The main outcome is nutritional adequacy measured at six months, with optional assessments at 12 months. Participants are followed as per normal clinical practice, with no experimental treatments assigned, allowing researchers to gather real-world information about KD's effects in this group.

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