NCT00968136已完成不适用
Short-term Ketogenic Diet as Compared With Conventional Long-term Trial in Refractory Infantile Spasms: A Randomized, Controlled Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 主要终点
- Primary outcome measures include seizure relapse and frequency after successful completion of the ketogenic diet.
研究概览
简要总结
This is a randomized, controlled study to compare Short-term ketogenic diet with conventional long-term trial in refractory infantile spasms.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients, who have recalcitrant infantile spasms and undertake the ketogenic diet at Severance Hospital and Sanggye Paik Hospital from 2005 to
- •Clinical and electroencephalography findings are compatible with infantile spasms
- •Spasms are intractable to the initial combination of vigabatrin (150 mg/kg) and topiramate (10 mg/kg) and/or additional indicated anti-epileptic drugs including prednisolone (2 mg/kg for 2 weeks and an additional 2 weeks for tapering).
- •Study entry requires magnetic resonance imaging to confirm the absence of a progressive cerebral lesion.
排除标准
- •Patients who have a history of hyperlipidaemia and underlying metabolic diseases including acute intermittent porphyria, pyruvate carboxylase deficiency, and fatty acid oxidation defects.
- •Patients who have a history of nephrolithiasis.
结局指标
主要结局
Primary outcome measures include seizure relapse and frequency after successful completion of the ketogenic diet.
时间窗: Finally, 35 patients could be followed up for more than 12 months after successful discontinuation of the diet and then primary outcome will be measured.
次要结局
未报告次要终点
研究者
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