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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2021-10-31

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.

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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.

Conditions

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Drug Resistant Epilepsy Ketogenic Diet Feasibility Tolerability Efficacy Children

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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The feasibility of the ketogenic diet

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

Group Type EXPERIMENTAL

Ketogenic diet

Intervention Type DIETARY_SUPPLEMENT

The ketogenic diet (KD) has been shown as an effective alternative for patients with drug-resistant epilepsy

the tolerability of 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

Group Type EXPERIMENTAL

Ketogenic diet

Intervention Type DIETARY_SUPPLEMENT

The ketogenic diet (KD) has been shown as an effective alternative for patients with drug-resistant epilepsy

the efficacy of 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.

Group Type EXPERIMENTAL

Ketogenic diet

Intervention Type DIETARY_SUPPLEMENT

The ketogenic diet (KD) has been shown as an effective alternative for patients with drug-resistant epilepsy

Interventions

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Ketogenic diet

The ketogenic diet (KD) has been shown as an effective alternative for patients with drug-resistant epilepsy

Intervention Type DIETARY_SUPPLEMENT

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