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

Number 2 Children's Hospital, Ho Chi Minh City

Status: Completed

Conditions: Drug Resistant Epilepsy; Feasibility; Ketogenic Diet; Children; Efficacy; Tolerability

Treatments: Dietary Supplement: Ketogenic diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05697887

CH2HCM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 1 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

45 participants in 3 patient groups

The feasibility of the ketogenic diet

Experimental group

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

Treatment:

Dietary Supplement: Ketogenic diet

the tolerability of the ketogenic diet

Experimental group

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

Treatment:

Dietary Supplement: Ketogenic diet

the efficacy of the ketogenic diet

Experimental group

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.

Treatment:

Dietary Supplement: Ketogenic diet