Efficacy of Modified Atkins Diet Versus Ketogenic Diet in Children With Refractory Epilepsy Aged 1 Year to 18 Years: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percentage of seizure reduction at 6 months ( sz frequency / wk average of 4 wks) from base line
研究概览
简要总结
In children aged 1yr -18 years with refractory epilepsy Modified Atkins diet as add on to ongoing AED therapy would not be inferior compared to ketogenic diet ** in terms of seizure reduction from baseline seizure frequency at 6 months
详细描述
Primary objective:
To compare the efficacy of Modified Atkins diet compared to Ketogenic diet * in children aged 1 year to 18 years of age with refractory epilepsy on anti epileptic drugs at 6 months of diet intake in terms of percentage of seizure reduction from base line.
Secondary objective:
Proportion of patients who achieve > 50% seizure reduction from baseline after 6 months in both groups To evaluate the nature of adverse events in both the groups
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 1-18 years with refractory epilepsy*
- •Willing to come for regular follow up
- •No motivational or psychosocial issues in the family which would preclude compliance with the diet
排除标准
- •Surgically remediable cause for refractory epilepsy
- •Suspected mitochondrial disorder or diagnosed with a disorder in which high fat diet is contraindicated
- •Previously received ketogenic diet or modified Atkins diet
- •Chronic systemic disease like chronic kidney disease, chronic liver disease, heart disease (congenital and acquired) and chronic respiratory illness
研究组 & 干预措施
ketogenic diet
ketogenic diet (2.5 to 4:1)
干预措施: Ketogenic diet (2.5 to 4:1) (Other)
Modifid Atkin's diet
Modified Atkin's Diet
干预措施: Modified Atkin's diet (Other)
结局指标
主要结局
Percentage of seizure reduction at 6 months ( sz frequency / wk average of 4 wks) from base line
时间窗: Baseline and 6 months
To develop an optimal dietary therapy for management of refractory epilepsy in children and adolescents
次要结局
未报告次要终点
研究者
Sheffali Gulati
Addl. Professor
All India Institute of Medical Sciences