Effects of Mega-dose Vitamin D Pulse and Maintenance Therapy on Seizure Frequency, Fatigue, and Quality of Life: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- seizure frequency
研究概览
简要总结
This prospective study aims to evaluate the effects of mega-dose vitamin D pulse therapy followed by maintenance therapy on seizure frequency, fatigue, and quality of life in patients with epilepsy. Participants will receive vitamin D supplementation, and clinical outcomes will be assessed over time to determine its potential benefits on seizure control and patient-reported outcomes.
详细描述
This is a prospective study designed to investigate the clinical effects of vitamin D supplementation in patients with epilepsy. Participants will receive a high-dose vitamin D pulse therapy followed by maintenance dosing. The study will assess changes in seizure frequency, fatigue, and quality of life over the study period. Clinical data will be collected longitudinally, and comparisons will be made to evaluate treatment effectiveness. This study aims to explore whether vitamin D supplementation can serve as a potential adjunctive therapy in epilepsy management.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 20 or above (inclusive)
- •Diagnosed patients (refractory epilepsy refers to those who have used more than two drugs, and each drug has reached the When epileptic seizures cannot be well controlled at standard reasonable treatment doses, it is called refractory epilepsy)
- •There is no imaging evidence of persistence or expansion of brain damage in the past three years
- •Subjects or family members (caregivers) can comply with the trial plan and take vitamin D patients
排除标准
- 未提供
研究组 & 干预措施
Placebo
干预措施: Placebo (Other)
Vitamin D
干预措施: Placebo (Other)
Vitamin D
干预措施: Vitamin D (Other)
Placebo
干预措施: Vitamin D (Other)
结局指标
主要结局
seizure frequency
时间窗: three time points: before starting the medication, one month after starting the medication, and three months after starting the medication.
Seizure frequency (number of seizures per month), assessed at baseline, 1 month, and 3 months after initiation of vitamin D therapy.
次要结局
- fatigue(before starting the medication and three months after starting it.)
- Quality of life(before starting the medication and again three months after treatment)
- Serum tests(three time points: before starting the medication, one month after starting it, and three months after starting it.)
- Quality of life score (QOLIE-31)(before starting the medication and again three months after treatment)
- Fatigue severity score (Fatigue Severity Scale)(before starting the medication and three months after starting it.)
- Serum vitamin D levels (25-hydroxyvitamin D)(three time points: before starting the medication, one month after starting it, and three months after starting it.)
研究者
Chin-Wei Huang
Professor
National Cheng-Kung University Hospital