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

Not Applicable

Completed

• Conditions: Feasibility; Drug Resistant Epilepsy; Children; Efficacy; Ketogenic Diet; Tolerability
• Interventions: Dietary Supplement: Ketogenic diet

• Registration Number: NCT05697887
• Lead Sponsor: Number 2 Children's Hospital, Ho Chi Minh City

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.

Study Timeline

• Study Start: 2019-06-01
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31
• Study First Submitted: 2022-12-29
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-15
• Last Update Submitted: 2023-01-15
• Study First Posted: 2023-01-26
• Last Update Posted: 2023-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
the efficacy of the ketogenic diet	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.
The feasibility of the ketogenic diet	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
the tolerability of the ketogenic diet	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

Primary Outcome Measures

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

Trial Locations

Locations (1)

N02 Children's Hospital; 🇻🇳 Ho Chi Minh city, Ho Chi Minh, Vietnam