Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004729
Status:
COMPLETED
Last Update Posted:
2006-12-22
First Post:
2000-02-25
Brief Title:
Ketogenic Diet for Child Epilepsy and Seizure Control
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institute of Neurological Disorders and Stroke NINDS
Study Overview
Official Title:
Efficacy of the Ketogenic Diet -- a Blinded Study
Status:
COMPLETED
Status Verified Date:
2006-12
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:
Twenty to thirty percent of children with epilepsy continue to suffer from seizures even when treated with currently available anticonvulsant medications Children with Lennox-Gastaut Syndrome LGS are particularly handicapped by atonic-myoclonic seizures Preliminary data suggest that even when other medications have failed these seizures may respond rapidly and dramatically to a high-fat-low-carbohydrate ketogenic diet The purpose of the study is to assess if the classic ketogenic diet is efficacious in reducing seizure frequency medication toxicity and improves quality of life
Detailed Description:
The ketogenic diet KD is a form of therapy for seizures that involves a brief period of fasting followed by a very carefully controlled high fat-low protein and carbohydrate diet Studies suggest it is useful in children whose seizures could not be controlled by any of the medicines available This study is designed to test in a carefully controlled fashion how well the diet works in children with drop seizures Children who experience 15 or more drop seizures each day despite having used at least two medications may be eligible to participate This study requires children to undergo periods of fasting and to maintain a carefully controlled diet Parents of participating children monitor their childrens diets and keep daily meal and seizure diaries
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: