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

Autism Spectrum Disorder Clinical Trial

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

Status Recruiting

Clinical Trial 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

Clinical Trial Description

Scientific and clinical interest in KD is growing with a progressive increase in its therapeutic indications, ie recent studies show beneficial effects of KD in other diseases like migraine, autism spectrum disorder and brain tumors.

However, so far, the majority of results on KD effects have been collected in patients with drug-resistant epilepsy proving its effectiveness on clinical outcome (e.g. reducing epileptic seizures), frequently leaving out the nutritional assessment and the impact on quality of life. Nonetheless, these factors are indeed essential to ensure safety and efficacy of KD treatment, especially when dealing with children and in perspective of the progressive expansion of the target population that can benefit from this nutritional therapy.

The present multicenter study aims to analyse these poorly explored areas, by evaluating, in a cohort of pediatrics patient with indication to KD therapy, not only the KD effectiveness on the course of the underlying disease, but also the impact on nutritional parameters (e.g. growth, lipid profile, vitamin intake, bone mineral density, ..) and on quality of life. ;

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Brain Tumor, Pediatric
• Chronic Migraine
• Drug Resistant Epilepsy

• NCT number: NCT06309251
• Study type: Observational
• Source: Danone Nutricia SpA Società Benefit
• Contact: Antonella Diamanti, MD
• Phone: +39 06 6859 2189
• Email: antonella.diamanti@opbg.net
• Status: Recruiting
• Start date: March 1, 2022
• Completion date: May 31, 2026