Feasibility, Tolerability and Efficacy of the Ketogenic Diet in Children With Drug-resistant Epilepsy in South Vietnam

Study Overview
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Brief Summary
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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
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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.

Official Title
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Feasibility, Tolerability and Efficacy of the Ketogenic Diet in Children With Drug-resistant Epilepsy in South Vietnam

Conditions
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Drug Resistant Epilepsy, Ketogenic Diet, Feasibility, Tolerability, Efficacy, Children

Intervention / Treatment
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* Dietary Supplement: Ketogenic diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The feasibility of the ketogenic diet<br>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 | Dietary Supplement: Ketogenic diet<br>* The ketogenic diet (KD) has been shown as an effective alternative for patients with drug-resistant epilepsy<br>|
| Experimental: the tolerability of the ketogenic diet<br>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 | Dietary Supplement: Ketogenic diet<br>* The ketogenic diet (KD) has been shown as an effective alternative for patients with drug-resistant epilepsy<br>|
| Experimental: the efficacy of the ketogenic diet<br>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. | Dietary Supplement: Ketogenic diet<br>* The ketogenic diet (KD) has been shown as an effective alternative for patients with drug-resistant epilepsy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The feasibility of the ketogenic diet | Number of drug-resistant epilepsy patients without ketogenic diet's contra-indication | 12 months | 
| The tolerability of the ketogenic diet at 12 months | Number of participants without ketogenic diet's side effect at 12 months | 12 months | 
| The efficacy of the ketogenic diet at 12 months | The number of participants had a 50% seizure decrease at 12 months | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug resistant epilepsy, ketogenic diet