Effect of Vitamin D3 Supplementation on Brain Waves in Male Epileptic Patients With Hypovitaminosis D: A Quantitative Electroencephalogram Analysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Vitamin D3 supplementation has positive effect on brain waves in male epileptic patients with hypovitaminosis D that can be proved by quantitative electroencephalogram.
研究概览
简要总结
This is an experimental study (interventional self-controlled trial, pretest-post test design). The goal of this clinical trial is to evaluate the effect of vitamin D3 supplementation on quantitative EEG in male epileptic patients with hypovitaminosis D.
. The main question it aims to answer is:
Vitamin D3 supplementation has effect on brain waves in male epileptic patients with hypovitaminosis D.
Researcher will compare the effect of Vitamin D3 supplementation on brain waves in male epileptic patients with hypovitaminosis D with their pre-intervention (baseline) condition on brain waves to assess whether there will be any improvement of brain electrical activity by quantitative electroencephalogram (QEEG).
Participants will:
Take Vitamin D3 orally for 8 weeks (50,000IU/week) Visit the medical university after 8 weeks for evaluation of serum 25 (OH) D level and quantitative electroencephalogram (QEEG) Must bring the empty strips of Vitamin D supplement with them during their visit
详细描述
This experimental study (self-controlled trial) will be conducted by the Department of Physiology, Bangladesh Medical University, Shahbag, Dhaka from March 2025-February 2026. For this study, a total number of 15 male patients with Epilepsy (age 20-40 years) will be enrolled as study participants according to selection criteria (Diagnosed male patients with Epilepsy by neurologist from the Out Patient Department of Department of Neurology by taking proper history of at least two unprovoked (or reflex) seizures occurring > 24 hours apart, from patients and eye witnesses, having Hypovitaminosis D (<30 ng/ml), Age: 20-40 years, BMI : 20 - 24 kg/m², On antiepileptic medication for 6 months to 2 years (enzyme inducing AEDs, e.g. Carbamazepine, Phenytoin, Phenobarbital), Without any medication that affect central nervous system other than antiepileptic drugs (Antidepressants, Antipsychotic, Anxiolytic, Anesthetic drugs), Apparently normal physical health ) At first baseline serum 25(OH) D level will be measured & baseline QEEG will be recorded. After that the participants will be supplemented vitamin D3 orally (50,000IU/week) for 8 weeks. After completion of 8 weeks, serum 25(OH) D level will be measured again & QEEG will be recorded.
To analyze brain electrical activities, the band power of alpha, beta, theta, and Delta brainwaves will be measured using an EEG Data gathering Device, the EEG Traveler BrainTech 32+ CMEEG-01 from India. The BT40 analysis software will be used to perform power spectral analysis of the EEG data. Mean ± SD will be used to express the data.
For statistical analysis, to compare the mean values between the pre intervention and post intervention sessions, paired t test will be done.The P value of ≤0.05 will be accepted as statistically significant. SPSS for Windows (version 25) will be used for the statistical analysis.
The findings of this study are expected to provide quantitative evidence regarding the neurophysiological effects of vitamin D3 supplementation in male epileptic patients with hypovitaminosis D.Also it could help people with epilepsy to lead healthier, more productive lives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosed male patients with Epilepsy by neurologist from the Out Patient Department of Department of Neurology, BMU by taking proper history of at least two unprovoked (or reflex) seizures occurring > 24 hours apart, from patients and eye witnesses.
- •Hypovitaminosis D (<30 ng/ml)
- •BMI : 20 - 24 kg/m²
- •On antiepileptic medication for 6 months to 2 years (enzyme inducing AEDs, e.g. Carbamazepine, Phenytoin, Phenobarbital)
- •Without any medication that affect central nervous system other than antiepileptic drugs (Antidepressants, Antipsychotic, Anxiolytic, Anesthetic drugs)
- •Apparently normal physical health
排除标准
- •Patients suffering from absence seizure
- •Certain AEDs (Sodium valproate, Ethosuximide, Oxcarbazepine, Topiramate, Lamotrigine, Levetiracetam)
- •Alcoholic
- •Known hypersensitivity to vitamin D3
- •Patients with hypertension
- •Patient with Thyroid disorder
- •Patient with Diabetes mellitus
- •Patient with Renal Disease
- •Patient with liver Disease
- •Patient with hypercalcemia
结局指标
主要结局
Vitamin D3 supplementation has positive effect on brain waves in male epileptic patients with hypovitaminosis D that can be proved by quantitative electroencephalogram.
时间窗: 8 weeks
15 male epileptic patients with serum 25(OH)D level less than normal, will be supplemented with vitamin D capsule 50,000 IU/WEEK for 8 weeks. That may have an effect on brain electrical activity (altering the power of different frequency brain waves) and ultimately change seizure frequency which can be assessed by quantitative EEG using Fast Fourier Transform method.
次要结局
未报告次要终点
研究者
Sumayya Binte Abdur Razzaque
MD resident
Bangladesh Medical University