Exploring the Effects of Genetic Variants and Inflammation on Individualized Treatment Outcomes of Vitamins Supplementation in Patient With Epilepsy
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Seizure severity
研究概览
简要总结
The management of patients with epilepsy is focused on controlling seizures, avoiding treatment side effects, and restoring quality of life. However, about 30% of people are antiepileptic drugs (AEDs) resistance epilepsy after the adequate trials of two AEDs treatment. Genetic factors may contribute to the high interindividual variability in response or adverse effects (such as weight gain and altered lipid profiles) to AEDs. What's more, previous observational studies indicated that vitamin deficiency, such as vitamin B6, is common in patients with epilepsy due to epilepsy itself, AEDs use, or both. Therefore, investigators aim to (1) evaluate the impact of genetic variants on AED and multi-vitamins supplementation in epilepsy, and (2) establish the pharmacogenomics knowledge base of AED and multi-vitamins supplementation on clinical effectiveness in patients with epilepsy.
详细描述
In the current study, investigators will evaluate the association among the genetic polymorphisms, epilepsy, and multi-vitamins supplementation from Taiwan Biobank and will further investigate potential genes related to vitamins signal pathways (especially vitamin B6, B9, D, E, and Q) involved in epilepsy. These results will not only generate the field of AEDs pharmacogenomics for further study, but also provide new potential treatment targets that may involve in epilepsy therapeutics. The clinical outcomes indicate disease severity, body weight, metabolic indices (i.e., the fasting levels of lipid), HRQoL, anxiety and depression scores. All outcome indicators will be repeated measured at baseline and after 1, 3 and 6 months multi-vitamins supplementation. All of the participants will be assessed the genotypes.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnostic criteria of epilepsy
- •Receive anti-epileptic drugs (AEDs)
排除标准
- •Have an organic mental disorder, mental retardation, dementia, or other diagnosed neurological illness
- •Have a surgical condition or a major physical illness
- •Pregnant or breast-feeding
结局指标
主要结局
Seizure severity
时间窗: 6 months
Number of seizure attack per month
次要结局
- Medication Compliance(6 months)