Feasibility, Tolerability and Efficacy of the Ketogenic Diet in Children With Drug-resistant Epilepsy in South Vietnam
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- The tolerability of the ketogenic diet at 12 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •clinical or laboratory features suggesting an underlying disease contra-indication the use of a ketogenic diet
研究组 & 干预措施
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
干预措施: Ketogenic diet (Dietary Supplement)
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
干预措施: Ketogenic diet (Dietary Supplement)
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.
干预措施: Ketogenic diet (Dietary Supplement)
结局指标
主要结局
The tolerability of the ketogenic diet at 12 months
时间窗: 12 months
Number of participants without ketogenic diet's side effect at 12 months
The feasibility of the ketogenic diet
时间窗: 12 months
Number of drug-resistant epilepsy patients without ketogenic diet's contra-indication
The efficacy of the ketogenic diet at 12 months
时间窗: 12 months
The number of participants had a 50% seizure decrease at 12 months
次要结局
未报告次要终点
研究者
Thuy-Minh-Thu NGUYEN
MD
Number 2 Children's Hospital, Ho Chi Minh City