Children, Drug Resistant Epilepsy, Efficacy, Feasibility, Ketogenic Diet, Tolerability
Conditions
Keywords
drug resistant epilepsy, ketogenic diet
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.
Interventions
DIETARY_SUPPLEMENTKetogenic diet
The ketogenic diet (KD) has been shown as an effective alternative for patients with drug-resistant epilepsy
Sponsors
Number 2 Children's Hospital, Ho Chi Minh City
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
1 Years to 10 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The feasibility of the ketogenic diet | 12 months | Number of drug-resistant epilepsy patients without ketogenic diet's contra-indication |
| The tolerability of the ketogenic diet at 12 months | 12 months | Number of participants without ketogenic diet's side effect at 12 months |
| The efficacy of the ketogenic diet at 12 months | 12 months | The number of participants had a 50% seizure decrease at 12 months |
Countries
Vietnam
Outcome results
None listed