Effect of Vitamin D3 Supplementation on Cardiac Autonomic Nerve Function in Male Epileptic Patients With Hypovitaminosis D
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 effects on cardiac autonomic nerve function in male epileptic patients with hypovitaminosis D.
研究概览
简要总结
The goal of this clinical trial is to see the effect of vitamin D3 supplementation on cardiac autonomic nerve function in male epileptic patients with hypovitaminosis D that weather vitamin D improves heart rate variability or not. The main questions it aims to answer are:
- Does vitamin D improves cardiac autonomic tone in male epileptic patients?
- Does vitamin D improves heart rate variability in male epileptic patients?
It is a self control trial. Participants will:
- undergo through baseline HRV testing
- start to take vitamin D3 50000 IU once in a week for 8 weeks
b) visit the university after 8 weeks for post interventional HRV testing . Researcher will compare the pre test and post test value of HRV testing.
详细描述
In epilepsy, there is a shifting of autonomic balance toward sympathetic dominance & heart rate variability (HRV) is reduced which can be detected by interictal heart rate variability (HRV) testing. Patients treated with anti-epileptic drugs (AEDs) are suffered from one of its major adverse effects of vitamin D3 deficiency or hypovitaminosis D due to enzyme inducing effect of AEDs. Vitamin D3 is a neuroprotective hormone that modulates autonomic balance and regulates sympathetic and parasympathetic nervous systems. Vitamin D3 deficiency is also associated with the risk of reduced HRV. Administration of vitamin D3 in vitamin D3 deficient epileptic patients may improve their cardiac autonomic nerve function that can be interpreted by HRV.
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 OPD of Department of Neurology by taking proper history of at least two unprovoked (or reflex) seizures occuring > 24 hours apart, from patients and eye witnesses.
- •Having hypovitaminosis D (serum vitamin D3 level <30 ng/ml)
- •Age: 20-40 years.
- •Sex: Male
- •BMI : 18.5-24.9 kg/m2
- •Taking antiepileptic drug for 6 months to 2 years ( Enzyme inducer AEDs, e.g. Carbamazepine, Phenytoin, Phenobarbital)
- •Without medication that affect central nervous system other than antiepileptic drugs (AEDs).
排除标准
- •• Epileptic patients taking Sodium valproate, oxcarbazepine, Topiramate, Lamotrigine, Levetiracetam.
- •Patient having absence seizure
- •Alcoholic
- •Patients taking following drugs will be excluded-
- •Anti-diabetic drugs
- •Antioxidant vitamin supplements
- •Antihypertensive drug
- •Anti-arrhythmic drug
- •Lipid lowering medications
- •Sedatives
- •Patients having known hypersensitivity to vitamin D3
- •All patients with the history of or currently suffering from following diseases & condition will be excluded-
- •Cardiovascular disorders (Myocardial infarction, coronary heart disease, cardiac arrhythmia, CCF)
- •Other neurological disorders (Migraine, stroke)
- •Respiratory disorders (Bronchial asthma, COPD)
- •Renal insufficiency (S. Creatinine > 1.5 mg/dl, Acute or chronic kidney disease)
- •Endocrine disease (Diabetes mellitus, Thyroid disorders- hypothyroidism, hyperthyroidism)
- •Arthritis (rheumatoid arthritis)
- •Liver diseases
- •Neoplastic disease
- •Psychiatric disorder (schizophrenia, bipolar disorder)
- •Current use of iron, zinc, calcium, magnesium and multivitamin supplementation
- •Already performing yoga or breathing exercise
- •Patients with hypercalcemia
结局指标
主要结局
Vitamin D3 supplementation has effects on cardiac autonomic nerve function in male epileptic patients with hypovitaminosis D.
时间窗: 8 weeks
In epilepsy, cardiac autonomic nerve function is altered which can be measured by heart rate variability test(HRV). HRV is reduced in epilepsy. Vitamin D3 supplementation in patients with epilepsy will improve their cardiac autonomic nerve function which can be detected by measuring various parameters of HRV test such as SDRR, LF(Low frequency).
Vitamin D3 supplementation has effects on cardiac autonomic nerve function in male epileptic patients with hypovitaminosis D.
时间窗: 8 weeks
In epilepsy, cardiac autonomic nerve function is altered which can be measured by heart rate variability test(HRV). HRV is reduced in epilepsy. Vitamin D3 supplementation in patients with epilepsy will improve their cardiac autonomic nerve function which can be detected by measuring various parameters of HRV test such as SDRR, LF(Low frequency).
次要结局
未报告次要终点
研究者
Samikha Sarker
Principal Investigator
Bangladesh Medical University