Back to resultsFeasibility, Tolerability and Efficacy of the Ketogenic Diet in Children With Drug-resistant Epilepsy in South Vietnam
Primary Purpose
Drug Resistant Epilepsy, Ketogenic Diet, Feasibility
Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Ketogenic diet
Sponsored by
About this trial
This is an interventional treatment trial for Drug Resistant Epilepsy focused on measuring drug resistant epilepsy, ketogenic diet
Eligibility Criteria
Inclusion Criteria: age from 1 to 10 years at the time of enrolment, drug-resistant epilepsy according to the 2010 ILAE criteria, an indication for a ketogenic diet trial according to the 2018 ILAE recommendations Exclusion Criteria: - clinical or laboratory features suggesting an underlying disease contra-indication the use of a ketogenic diet
Sites / Locations
- N02 Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
The feasibility of the ketogenic diet
the tolerability of the ketogenic diet
the efficacy of the ketogenic diet
Arm Description
The purpose of this study was to verify the feasibility of the ketogenic diet in children with refractory epilepsies followed at a pediatric center in South Vietnam. The patient was considered feasible if he (or she) did not have the contra-indication for the ketogenic diet
The purpose of this study was to verify the tolerability of the ketogenic diet in children with refractory epilepsies followed at a pediatric center in South Vietnam. The patient was considered tolerant if he (or she) did not have any side effects caused by the ketogenic diet
The purpose of this study was to verify the efficacy of the ketogenic diet in children with refractory epilepsies followed at a pediatric center in South Vietnam. Patients were considered responders when a 50% seizure frequency was reached.
Outcomes
Primary Outcome Measures
The feasibility of the ketogenic diet
Number of drug-resistant epilepsy patients without ketogenic diet's contra-indication
The tolerability of the ketogenic diet at 12 months
Number of participants without ketogenic diet's side effect at 12 months
The efficacy of the ketogenic diet at 12 months
The number of participants had a 50% seizure decrease at 12 months
Secondary Outcome Measures
Full Information
NCT ID
NCT05697887
First Posted
December 29, 2022
Last Updated
January 15, 2023
Sponsor
Number 2 Children's Hospital, Ho Chi Minh City
1. Study Identification
Unique Protocol Identification Number
NCT05697887
Brief Title
Feasibility, Tolerability and Efficacy of the Ketogenic Diet in Children With Drug-resistant Epilepsy in South Vietnam
Official Title
Feasibility, Tolerability and Efficacy of the Ketogenic Diet in Children With Drug-resistant Epilepsy in South Vietnam
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Number 2 Children's Hospital, Ho Chi Minh City
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
According to the World Health Organization, more than 50 million people have epilepsy. Among them, nearly 80% of epileptic patients live in developing countries and 75% of them do not have access to treatment. The ketogenic diet (KD) has been shown as an effective alternative for patients with drug-resistant epilepsy. Although it has been studied by few studies in Asia, no such studies have been conducted in Vietnam. The purpose of this study was to verify the feasibility, tolerability, and efficacy of the KD in children with refractory epilepsies followed at a pediatric center in South Vietnam.
Detailed Description
Children with drug-resistant epilepsy followed at Children's Hospital No.2, Viet Nam treated by KD were included in a prospective study from June 2019 to October 2021. Side-effects, retention rate, number, and duration of seizures were recorded after 1, 3, 6, 9, and 12 months of KD. Patients were considered as responders when a 50% seizure frequency was reached. Tolerance and acceptability of the KD were closely monitored.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Resistant Epilepsy, Ketogenic Diet, Feasibility, Tolerability, Efficacy, Children
Keywords
drug resistant epilepsy, ketogenic diet
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Children with drug-resistant epilepsy followed at Children's Hospital No.2, Viet Nam treated by KD were included in a prospective study from June 2019 to October 2021. Side-effects, retention rate, number, and duration of seizures were recorded after 1, 3, 6, 9 and 12 months of KD. Patients were considered as responder when a 50% seizure frequency was reached. Tolerance and acceptability of the KD were closely monitored.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The feasibility of the ketogenic diet
Arm Type
Experimental
Arm Description
The purpose of this study was to verify the feasibility of the ketogenic diet in children with refractory epilepsies followed at a pediatric center in South Vietnam. The patient was considered feasible if he (or she) did not have the contra-indication for the ketogenic diet
Arm Title
the tolerability of the ketogenic diet
Arm Type
Experimental
Arm Description
The purpose of this study was to verify the tolerability of the ketogenic diet in children with refractory epilepsies followed at a pediatric center in South Vietnam. The patient was considered tolerant if he (or she) did not have any side effects caused by the ketogenic diet
Arm Title
the efficacy of the ketogenic diet
Arm Type
Experimental
Arm Description
The purpose of this study was to verify the efficacy of the ketogenic diet in children with refractory epilepsies followed at a pediatric center in South Vietnam. Patients were considered responders when a 50% seizure frequency was reached.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketogenic diet
Intervention Description
The ketogenic diet (KD) has been shown as an effective alternative for patients with drug-resistant epilepsy
Primary Outcome Measure Information:
Title
The feasibility of the ketogenic diet
Description
Number of drug-resistant epilepsy patients without ketogenic diet's contra-indication
Time Frame
12 months
Title
The tolerability of the ketogenic diet at 12 months
Description
Number of participants without ketogenic diet's side effect at 12 months
Time Frame
12 months
Title
The efficacy of the ketogenic diet at 12 months
Description
The number of participants had a 50% seizure decrease at 12 months
Time Frame
12 months
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:
age from 1 to 10 years at the time of enrolment,
drug-resistant epilepsy according to the 2010 ILAE criteria,
an indication for a ketogenic diet trial according to the 2018 ILAE recommendations
Exclusion Criteria:
- clinical or laboratory features suggesting an underlying disease contra-indication the use of a ketogenic diet
Facility Information:
Facility Name
N02 Children's Hospital
City
Ho Chi Minh city
State/Province
Ho Chi Minh
ZIP/Postal Code
848
Country
Vietnam
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Feasibility, Tolerability and Efficacy of the Ketogenic Diet in Children With Drug-resistant Epilepsy in South Vietnam
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