Ketogenic Diet for Child Epilepsy and Seizure Control
Primary Purpose
Epilepsy, Seizures, Lennox-Gastaut Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ketogenic diet
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring child, children, epilepsy, seizure, ketogenic, diet, Lennox-Gastaut Syndrome, LGS
Eligibility Criteria
Inclusion Criteria: >15 myoclonic or atonic seizures a day EEG with Lennox-Gastaut pattern Exclusion Criteria: <15 atonic or myoclonic seizures a day on >3 medications previously on diet and/or evidence of metabolic disorder
Sites / Locations
- Johns Hopkins Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00004729
First Posted
February 25, 2000
Last Updated
December 21, 2006
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
1. Study Identification
Unique Protocol Identification Number
NCT00004729
Brief Title
Ketogenic Diet for Child Epilepsy and Seizure Control
Official Title
Efficacy of the Ketogenic Diet -- a Blinded Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
July 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
4. Oversight
5. Study Description
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 children's diets and keep daily meal and seizure diaries.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Seizures, Lennox-Gastaut Syndrome
Keywords
child, children, epilepsy, seizure, ketogenic, diet, Lennox-Gastaut Syndrome, LGS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Ketogenic diet
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
>15 myoclonic or atonic seizures a day
EEG with Lennox-Gastaut pattern
Exclusion Criteria:
<15 atonic or myoclonic seizures a day
on >3 medications
previously on diet and/or evidence of metabolic disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John M. Freeman
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
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Ketogenic Diet for Child Epilepsy and Seizure Control
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