Comparison of Efficacy of Low Glycemic Index Therapy and Modified Atkins Diet Among Children With Drug Resistant Epilepsy: A Randomized Non-inferiority Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Percentage of seizure reduction from baseline at 24 weeks of therapy
研究概览
简要总结
To compare the efficacy of two less restrictive dietary therapies - LGIT and MAD, used for treatment of drug resistant epilepsy in children
详细描述
Up to one third of patients with epilepsy progress to drug resistant epilepsy (DRE). Current treatment options for DRE include epileptic surgery and dietary therapy. Classic KD (Ketogenic diet) is the most studied dietary therapy but the stringent restrictions and practical difficulty makes it difficult to follow. So less restrictive diets like MAD and LGIT were introduced. These are reported to have less adverse effects also. But no published study has ever been conducted comparing these two diets head to head.
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 according to study protocol Drug resistant epilepsy defined as
- •Seizure frequency >4 seizures per month, while on optimal doses of at least 2 prescribed antiepileptic drugs
- •For West syndrome, drug resistant epilepsy will be defined as more than 4 clusters of spasms per month despite treatment with antiepileptic drugs and either ACTH(Adrenocorticotrophic hormone) or Vigabatrin
排除标准
- •Surgically remediable causes for DRE
- •Inborn errors of metabolism
- •Previously received KD, MAD or LGIT
- •Known case of
- •Chronic kidney disease
- •Chronic liver disease/GI illness
- •Congenital/acquired heart disease
- •Chronic respiratory illness
研究组 & 干预措施
Low Glycemic Index therapy
Specific dietary therapy called Low glycemic Index Therapy (LGIT) which provides diet including food items with glycemic index less than 50 only
干预措施: Low glycemic Index Therapy (LGIT) (Other)
Modified Atkins Diet
Specific dietary therapy called Modified Atkins Diet (MAD) which provides diet with restricted carbohydrates upto 20 grams per day and increased fat and protein ratio
干预措施: Modified Atkins Diet (MAD) (Other)
结局指标
主要结局
Percentage of seizure reduction from baseline at 24 weeks of therapy
时间窗: At the end of 24 weeks of dietary therapy
Mean weekly seizure reduction at 24 weeks divided by Mean weekly seizure measured at baseline multiplied by 100
次要结局
- Change in Quality of Life of participants who are more than or equal to 4 years of age at 24 weeks as compared to baseline(At the end of 24 weeks of dietary therapy)
- Change in behavioral abnormalities with each dietary therapy(At the end of 24 weeks of dietary therapy)
- Change in Quality of Life of participants who are less than 4 years of age at 24 weeks as compared to baseline(At the end of 24 weeks of dietary therapy)
- Gut microbiota (GM) analysis pre and post dietary therapy(At the end of 24 weeks of dietary therapy)
- Change in Social quotient(SQ) with each dietary therapies(At the end of 24 weeks of dietary therapy)
- Proportion of children who achieve >50% seizure reduction(At the end of 24 weeks of dietary therapy)
- Incidence of adverse events(At the end of 24 weeks of dietary therapy)
- Compliance of participants with dietary therapy in each arm will be determined each week, whether satisfactory or unsatisfactory(At the end of 24 weeks of dietary therapy)
- Change in Quality of Life of caregivers at 24 weeks as compared to baseline(At the end of 24 weeks of dietary therapy)
研究者
Sheffali Gulati
Professor, Chief, Child Neurology Division
All India Institute of Medical Sciences, New Delhi