Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06309251
Status:
RECRUITING
Last Update Posted:
2024-03-13
First Post:
2024-02-29
Brief Title:
Effectiveness and Impact on the Quality of Life of Ketogenic Diet in Pediatric Patients
Sponsor:
Danone Nutricia SpA Società Benefit
Organization:
Danone Nutricia SpA Società Benefit
Study Overview
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
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 questions 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
The main questions 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
Detailed 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 eg 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 eg growth lipid profile vitamin intake bone mineral density and on quality of life
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 eg 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 eg growth lipid profile vitamin intake bone mineral density and on quality of life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None