Development of an Indigenous Ketogenic Formula and Determination of its Efficacy, Safety and Tolerability in improving Seizure Outcome among A Cohort of Children with Drug Resistant Epilepsy in Tertiary Care Setting
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1. To develop indigenous, low cost and effective MCT based ketogenic formula which can be given orally as well as through NG feed.
研究概览
简要总结
Aim –
v To reduce the number of seizure episodes and to improve the urine ketone levels in children with Drug Resistant Epilepsy and those who are not willing for Epilepsy Surgery.
Study Objectives –
v To develop indigenous, low cost and effective MCT based ketogenic formula which can be given orally as well as through NG feed.
v To determine the efficacy of MCT based Ketogenic Diet in reducing the number of seizure episodes, achieving optimal ketosis and improving the urine ketone levels.
v To determine the compliance, safety and tolerability of MCT based ketogenic diet by checking for any possible side effects.
Need for the Study
- Evidence suggests that Ketogenic Diet and its variants are a good option for non-surgical pharmacoresistant patients with epilepsy. Studies have found that LDL cholesterol levels might get elevated in some patients following ketogenic diet. Studies have found MCTs have a role in improving lipid profiles in dyslipidemia conditions, namely by increasing HDL levels and lowering TG, total cholesterol, and LDL levels. Currently available Keto formulas are expensive and not affordable at a longer duration by patients/family. Therefore, there is a need to develop MCT based indigenous ketogenic formula which can be given orally as well as through tube feeding and which is cost effective, made up of natural ingredients, nutritious, effective and at same time can be acceptable by the patients. From the literature survey, it can be concluded that MCT based ketogenic diet plays a very important role and found to be effective in controlling seizure episodes among epileptic children. Also, very few studies have been conducted in India to show the effectiveness of ketogenic diet in treating childhood epilepsy. Thus, there is a need to study the efficacy, safety and tolerability of MCT based ketogenic diet by developing a MCT based Ketogenic Formula and supplementing it among Children with Epilepsy who are not controlled on antiseizure medications and those who are not amenable to surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Month(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •Children with Epilepsy (1month – 5 years) who are not controlled on anti seizure medications and those who are not willing for Epilepsy Surgery.
排除标准
- •Children with certain metabolic disorders such as defects in fatty acid oxidation, carnitine deficiency, and certain organic acidemias or those with history of pancreatitis, pre-existing liver conditions, gastrointestinal disorders and critically ill patients.
结局指标
主要结局
1. To develop indigenous, low cost and effective MCT based ketogenic formula which can be given orally as well as through NG feed.
时间窗: 6 months (For each child after 6 months of enrollment in the study primary outcome will be measured).
2. To determine the efficacy of MCT based Ketogenic Diet in reducing the number of seizure episodes, achieving optimal ketosis and improving the urine ketone levels.
时间窗: 6 months (For each child after 6 months of enrollment in the study primary outcome will be measured).
3. To determine the compliance, safety and tolerability of MCT based ketogenic diet by checking for any possible side effects.
时间窗: 6 months (For each child after 6 months of enrollment in the study primary outcome will be measured).
次要结局
未报告次要终点
研究者
Soma Basu
Sri Ramachandra Institute of Higher Education and Research