Effect of Vitamin D3 Supplementation on Cardiac Autonomic Nerve Function in Male
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 effect on cardiac autonomic nerve function in male Parkinson's disease patient
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 Parkinson's disease patients with hypovitaminosis D
Main questions it aims to answer are:
- Does vitamin D improves heart rate variability(HRV) in male Parkinson's disease patients ?
- Does vitamin D improves cardiac autonomic nerve function in male Parkinson's disease patients ? It is a self control trial. Vitamin D3 deficient Parkinson's disease participants will
a. undergo through baseline HRV test b. Then they will take vitamin D3 capsule 50000 IU once in a week for 8 consecutive weeks c. Then after intervention with vitamin D supplementation post interventional HRV will be done.
Researcher will compare pre intervention(pre test) and post intervention(post test) value of HRV
详细描述
In Parkinson's disease , there is a shifting of autonomic nerve function towards sympathetic dominance and Heart rate variability decrease. Reduced heart rate variability can be detected by Heart rate variability(HRV) testing.
In Parkinson's disease deposition of Lewy bodies (due to accumulation of alpha- synuclein protein ) causes degeneration of dopaminergic neuron. Parasympathetic nerve results from vagus nerve atrophy and simultaneous sympathetic denervation results in decrease HRV.
Hypovitaminosis D is commonly associated with Parkinson's disease due to alteration of gastrointestinal function, progressive skin atrophy, lack of mobilization, lack of sun exposure.
Vitamin D3 act as neuroprotective hormone and plays role in autonomic nervous system regulation and maintaining balance between sympathetic and parasympathetic nervous system. Vitamin D3 deficiency is associated with cardiac autonomic imbalance. Administration of vitamin D3 in vitamin D deficient Parkinson's patient may may improve 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
- 51 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •IInclusion criteria:
- •Male patients with of Parkinson's disease diagnosed by neurologist with unilateral or bilateral involvement and mild to moderate disability according to Hoehn and Yahr (H-Y) scale (I-III)
- •Age: 51-70 years
- •BMI: 18.5-24.9 kg/m2
- •Vitamin D3 deficient or insufficient
- •On Levodopa medication
排除标准
- •Patients with a history of drug abuse including alcoholism.
- •Patients on following drugs will be excluded-
- •Antioxidant vitamin supplements
- •Lipid lowering medications
- •Antihypertensive drug
- •Anti-arrhythmic drug
- •Sedatives
- •All patients with the history of or clinical manifestation of currently suffering from following diseases & condition will be excluded
- •Severe Cardiovascular disorders
- •Severe neurological disorders
- •Severe Respiratory disorders
- •Severe Renal insufficiency (S. Creatinine > 1.5 mg/dl, Acute or chronic kidney disease)
- •Severe Endocrine disease
- •Severe Arthritis
- •Severe Liver diseases
- •Severe Neoplastic disease
- •Severe Psychiatric disorder
- •Current use of iron, zinc, calcium, magnesium and multivitamin supplementation
- •Already performing yoga or breathing exercise
- •Hypercalcemia
结局指标
主要结局
Vitamin D3 supplementation has effect on cardiac autonomic nerve function in male Parkinson's disease patient
时间窗: 8 weeks
Altered cardiac autonomic nerve function
次要结局
未报告次要终点
研究者
Jobayda Binte Rahmatullah
MD Resident
Bangladesh Medical University