Comparison Between Efficacy of Daily and Intermittent Low Glycemic Index Therapy Diet Among Children With Drug Resistant Epilepsy Aged 1-15 Years: an Open Labeled Randomized Controlled Parallel Design Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Percentage of seizure reduction from baseline at 24 weeks in each arm
研究概览
简要总结
Drug resistant epilepsy constitutes about one third of all children diagnosed with epilepsy. Although ketogenic diet is being used for drug resistant epilepsy for almost hundred years, its restrictiveness and adverse effects interferes with its compliance. So less restrictive alternatives like Low Glycemic Index Therapy diet is gradually becoming more popular and its effectiveness is well established. Still the restrictiveness of such monotonous diets is one of the most significant issues for long term maintenance of children on dietary therapy. In this study, we are planning to compare the efficacy of daily and intermittent Low Glycemic Index therapy Diet in children aged 1-15 years with drug resistant epilepsy in a open labelled randomized controlled non-inferiority trial. The children in intermittent LGIT arm will receive the dietary therapy for five days of each week, alternating with a liberal diet on the rest of the two days of the week.
详细描述
Drug resistant epilepsy constitutes about one third of all children diagnosed with epilepsy. Although ketogenic diet is being used for drug resistant epilepsy for almost hundred years, its restrictiveness and adverse effects interferes with its compliance. So less restrictive alternatives like Low Glycemic Index Therapy diet is gradually becoming more popular and its effectiveness is well established. Still the restrictiveness of such monotonous diets is one of the most significant issues for long term maintenance of children on dietary therapy. In this study, we are planning to compare the efficacy of daily and intermittent Low Glycemic Index therapy Diet in children aged 1-15 years with drug resistant epilepsy in a open labelled randomized controlled non-inferiority trial. The children in intermittent LGIT arm will receive the dietary therapy for five days of each week, alternating with a liberal diet on the rest of the two days of the week. With a follow up period of 6 months, we are planning to enroll 55 children in each arm. Adverse effect profile in each arm will also be monitored during the study. Also the effect of the dietary therapy on behavior and cognition in each arm will be assessed.
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 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 1-15 years with drug resistant epilepsy
- •Willing to come for regular follow up
排除标准
- •Surgically remediable cause for drug resistant epilepsy
- •Proven in born error of metabolism except in which dietary therapy for epilepsy is indicated(i.e. pyruvate carboxylase deficiency and GLUT 1 deficiency)
- •Previously received KD, MAD or LGIT
- •Known case of
- •Chronic kidney disease
- •Chronic liver disease/GI illness
- •Chronic heart disease(congenital and acquired)
- •Chronic respiratory illness
研究组 & 干预措施
Daily LGIT
The children with drug resistant epilepsy in this arm will receive Low Glycemic Index Therapy diet everyday along with the antiepileptic drugs.
干预措施: Low Glycemic Index Therapy Diet (Dietary Supplement)
Intermittent LGIT
The children with drug resistant epilepsy in this arm will receive Low Glycemic Index Therapy Diet on five days of each week along with antiepileptic drugs. Rest of the two days, they will receive a liberal diet.
干预措施: Low Glycemic Index Therapy Diet (Dietary Supplement)
结局指标
主要结局
Percentage of seizure reduction from baseline at 24 weeks in each arm
时间窗: Percentage seizure reduction will be calculated for each child in each arm after 24 weeks follow up period is completed and finally mean seizure reduction in each arm will be computed at the end of 24 weeks
Percentage of seizure reduction from baseline at 24 weeks in each arm will be calculated from Daily Seizure Log maintained by parents Percentage of seizure reduction at 24 weeks=x-y/x X 100 Y=Mean daily seizures at 24 weeks as measured over past 4 weeks X=Mean daily seizures at baseline as measured over 4 weeks Seizure log will contain details of number, duration and type of seizures as recorded by parents
次要结局
- Proportion of patients with >50% seizure reduction in each dietary arm(At the end of 24 weeks, it will be determined the proportion of children in each arm with >50% reduction in seizure frequency.)
- Change in social quotient with each dietary therapy(Vineland Social Maturity Scale will be done for each child at baseline and at 24 weeks to calculate social quotient at baseline and 24 weeks)
- Proportion of patients with different clinical adverse events in each group(Each child will be monitored for adverse effects clinically at 12 weeks and 24 weeks)
- Correlate seizure frequency change at 24 weeks with blood HbA1c levels(Absolute level of HbA1c levels (in percentage) as compared to percentage change in seizure frequency at 3 and 6 months will be computed)
- Correlate seizure frequency change at 24 weeks with blood betahydroxy butyrate levels levels(Blood beta hydroxyl butyrate levels(milimoles/liter) at 12 and 24 weeks as compared to percentage change in seizure frequency will be computed)
- Proportion of patients with different biochemical adverse events in each group(Each child will be monitored by certain biochemical investigations like hemoglobin, liver and renal function tests and lipid profile at baseline, at 24 weeks and also in between if clinically indicated)
研究者
Sheffali Gulati
Professor and Chief, Child Neurology Division, Department of Pediatrics, AIIMS, New Delhi
All India Institute of Medical Sciences, New Delhi