NCT00181090已完成1 期
Use of the Atkins Diet for Children With Intractable Epilepsy: A Comparison of Daily Carbohydrate Limits
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Seizure control
研究概览
简要总结
This study is designed to further investigate the use of a modified Atkins diet for children with intractable, daily seizures. It is a follow-up to a study recently completed by our institution. In this 6-month study, children will be randomized to either 10 or 20 grams of carbohydrate per day, then crossed over to the opposite amount at 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 3-18
- •Daily seizures or 7 per week
- •Failed at least 2 anticonvulsants
排除标准
- •Prior use of the Atkins diet for over 1 week
- •Significant heart, liver, or kidney disease
结局指标
主要结局
Seizure control
时间窗: 6 months
Ketosis
时间窗: 6 months
次要结局
- Tolerability(6 months)
- Safety - cholesterol, kidney function, weight(6 months)
研究者
研究点 (2)
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