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临床试验/NL-OMON40609
NL-OMON40609已完成不适用

The modified Atkins diet in patients with refractory epilepsy and severe intellectual disability: a randomized controlled trial. - The modified Atkins diet in epilepsy: an RCT.

Tergooiziekenhuizen0 个研究点目标入组 29 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
29

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • Age > 18 years, moderate to severe ID;
  • Refractory epilepsy, defined as failure of two tolerated and appropriately chosen and used AED schedules;
  • More than two seizures per month, which are judged by the carers and the treating physician to impose a significant impact on the patients* QOL --justifying treatment;
  • Informed consent obtained by at least one legal representative;

排除标准

  • Undergone epilepsy surgery in the last 6 months, or awaiting pre-surgical evaluation;
  • Underwent implantation of a vagal nerve stimulation in the last 6 months;
  • Previous use of the MAD or the KD for more than 7 days in the last year prior to inclusion;
  • Hypercholesterolemia (total cholesterol >8), cardiovascular disease or kidney failure, metabolic disorders known to deteriorate after fasting;
  • Severe underweight, defined as a BMI < 16.5;
  • Diabetes Mellitus.

研究者

发起方
Tergooiziekenhuizen

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