NCT00564915已完成4 期
RCT of the Efficacy of the Ketogenic Diet in the Treatment of Epilepsy
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 2
- 主要终点
- Change in seizure frequency
研究概览
简要总结
A study of the efficacy and tolerability of two different ketogenic diets in children with drug resistant epilepsy; children resistant to at least two drugs randomised to reveive diet after baseline or after further 3m control period; in addition randomised to either MCT or classical ketogenic diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of epilepsy for at least 2 years, resistant to at least two AEDs, at least 7 seizures/week
排除标准
- 未提供
结局指标
主要结局
Change in seizure frequency
时间窗: 3 months
次要结局
- Tolerability and assessment of ketosis and growth(3 months)
研究者
研究点 (2)
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