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
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 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
- •Exclusion Criteria
- •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
排除标准
- 未提供
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, New Delhi