跳至主要内容
临床试验/NCT02216500
NCT02216500招募中不适用

Precision Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy

University of Florida2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2006年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
2
主要终点
Reduced seizures

研究概览

简要总结

Approximately a fourth of children with seizures do not respond adequately to available therapy. Ketogenic therapy has a long history as treatment for intractable epilepsy, but there is no agreement concerning how it works and what is the best way to administer it. This natural history study will collect data pertaining to both questions.

详细描述

The basis of Ketogenic Therapy is an altered macronutrient intake. It is based on a ratio of fat: protein+carbohydrate in which protein intake is adequate and carbohydrate is minimal. On Ketogenic Therapy, the body metabolizes fat, producing ketones as an energy source for the brain. Induction of ketosis has been shown to correlate with the reduction of seizures observed with Ketogenic Therapy. A major challenge of Ketogenic Therapy in children is that the compounds provided to stop seizure activity are the same compounds provided for growth and development. The altered macronutrient ratio that is the basis of Ketogenic Therapy is also a potential risk factor for dyslipidemia and may adversely affect growth. The investigators will evaluate efficacy of Ketogenic Therapy by assessing seizures and requirements for antiepileptic drugs. The investigators will evaluate adverse effects of Ketogenic Therapy by assessing dyslipidemia and growth. The investigators will foster optimal daily administration of therapy with structured training programs for caregivers.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients whose physician has prescribed the ketogenic diet
  • Patients with lab tests consistent with the ability to metabolize a high fat and low carbohydrate diet
  • Patients that can be compliant with administration of the therapy and with record keeping.

排除标准

  • Patients with lab tests consistent with the inability to metabolize a high fat and low carbohydrate diet
  • Patients at risk of being non-compliant with administration of the therapy and with record keeping

结局指标

主要结局

Reduced seizures

时间窗: 2 years

Seizures will be charted from collected data.

次要结局

  • Reduced requirement for medications(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验