Impact of Vitamin D3 Administration on Cardiac Autonomic Tone in Asthma COPD Overlap(ACO) Patients: A Blinded Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Ratio of Low frequency to High Frequency (HF) power in frequency domain parameters of heart rate variability
研究概览
简要总结
Title:Impact of vitamin D administration on cardiac autonomic tone in Asthma Chronic Obstructive Pulmonary Disease (COPD) Overlap patients: A blinded randomized control trial.
Background: Respiratory disease is closely associated with cardiovascular disease. Reduced Heart Rate Variability (HRV), reflecting impaired autonomic activity have been reported in both asthma and COPD. Vitamin D deficiency is a common feature in Asthma COPD Overlap (ACO) patient. Relationship between vitamin D deficiency and low HRV has been reported. Vitamin D administration has been reported to improve cardiac autonomic modulation in healthy subjects in response to external stressor. Objective: To assess the changes in cardiac autonomic tone after vitamin D administration for 90 days in vitamin D deficient ACO patients.
Hypothesis:Null: Vitamin D administration does not have impact on cardiac autonomic tone in vitamin D3 deficient ACO patient.
.Method: This randomized controlled trial will be conducted by Department of Physiology, Bangabandhu Sheikh Mujib Medical University (BSMMU), Shahbag, Dhaka from September' 2017 to August' 2018. For this study, a total number of 60 subjects (age > 40 years, both male and female) will be randomly selected. 30 diagnosed vitamin D deficient Asthma COPD Overlap (ACO) patients will form group A and another 30 diagnosed vitamin D3 deficient ACO patients with similar age, sex, (Body Mass Index) BMI will constitute control group B. Patients of study group B0 will take vitamin D3 with a prescribed schedule for 3 months and followed up after 3 months (group B90). On the other hand patients of group A1 will be given placebo and followed up after 3 months (group A90). All these patients will continue their medication prescribed by physician during these 3 months. On the basis of data recording - group B1 and group B90 will constitute pre and post vitamin D group whereas group A0 and group A90 will represent pre and post placebo follow up at day 0 and day 90. Cardiac autonomic nerve function will be assessed by recording ECG & Heart Rate Variability (HRV) analysis by a data acquisition device, powerlab 8/35, AD instruments, Australia. HRV measures of all patients will be recorded at baseline.Then after 3 months of follow up it will be recorded in both groups at day 90. Serum 25(OH)D level will be measured of all subject at day 0 and day 90. For statistical analysis unpaired and paired "t" test will be done by using Microsoft Office Excel Word version 2016
详细描述
Previous studies reported earlier age of onset, symptom with longer duration, more exacerbation and devoid of adequate health care in Asthma Chronic Obstructive Pulmonary Disease (COPD) Overlap (ACO) patients compared to asthma and Chronic Obstructive Pulmonary Disease (COPD) alone. However their prevalence rate was reported between 15 and 55%. Existence of asthma and COPD has been reported in between 15-20% of patient. There is no population based data on ACO patients in Bangladesh. But one study very recently reported 11.6% of Asthma COPD Overlap (ACO) patients in this country. Thus it is of utmost importance to perform more research on this significant disease.
Several studies investigated autonomic function in asthma and COPD patients. Both asthma and COPD affect cardiac autonomic function. Poor asthma control is associated with lower HRV, depressed sympathetic and enhanced parasympathetic modulation. It has reported that the risk of cardiovascular disease in COPD is increase by 2 to 3 fold and it is the leading cause of death in mild to moderate COPD. But to the best of our knowledge no study investigated the cardiac autonomic function of ACO patients.
Vitamin D deficiency is a common feature in ACO patient. Previous studies demonstrated the relationship between vitamin D deficiency and reduced HRV resulting in incidence of cardiovascular disease. Only one study reported the effect of vitamin D administration on HRV. They enrolled young healthy subjects and observed the effect of vitamin D on HRV in response to physiological stressor such as angiotensin II induced stress. All these subjects were vitamin D insufficient and their result showed improvement of sympathovagal balance after administration of vitamin D. With this experimental observation we can expect, administration of vitamin D in vitamin deficient ACO patients might improve cardiac autonomic function and thereby protect them from the risk cardiovascular morbidity and mortality.
However vitamin D appears to be a simple, cost effective treatment to reduce cardiovascular disease associated risk by improving function of autonomic nerve function in both healthy and chronic disease population worldwide. But the volume of information regarding the effect of vitamin D administration in ACO patients is not enough for reaching any final conclusion. Moreover, with the best of our knowledge no study have been conducted to observe the effects of this fat soluble vitamin on HRV in vitamin D deficient, stable patients with ACO.
Therefore, on the basis of this background the present study has been designed to evaluate the effects of Vitamin D on heart rate variability in D deficient, stable patients with ACO. This study will draw attention of the physicians on the cardiac autonomic status of ACO patients and the effects of Vitamin D on it.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
Both the patients and the principal investigator will remain blind to the intervention given. After the end of follow up, at the time of data analysis principal investigator will be provided with the information about which patient isgoven placebo and which patient isgivev drug.
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •• 40-80 years of age
- •Middle class of socioeconomic condition:.
- •Stable patients of Asthma COPD Overlap (ACO) with >4 years of disease duration.
- •Vitamin D deficient (Serum 25-hydroxycholecalciferol, 25(OH)D level < 30 ng/ml).
- •Normal serum Ca+and inorganic phosphate level.
- •Hypertension with ACO.
- •Diabetes with ACO
排除标准
- •Unstable patients with ACO (patients with exacerbation and medication changes in the past 30 days)
- •With acute exacerbation of any pulmonary diseases, such as,
- •Bronchial asthma
- •Acute respiratory tract infection
- •Current tuberculosis
- •Pleural effusion
- •Emphysematous bullae
- •Interstitial lung disease
- •Pneumonectomy or pulmonary lobectomy
- •Pulmonary fibrosis.
- •With acute exacerbation of any cardiac disease, like -
- •Unstable angina pectoris
- •Congestive heart failure
- •Myocardial infarction
- •Cardiac arrhythmia
- •Rheumatoid arthritis.
- •Inflammatory bowel disease.
- •Chronic Renal Failure.
- •Systemic lupus erythromatosIs.
- •Musculoskeletal diseases.
- •Any malignancy
- •Systemic hypertension
- •Use of drugs known to affect Central Nervous System (CNS) and vitamin D metabolism within 1 month prior to study, as,
- •Antiepileptics (Phenytoin, Carbamazepine)
- •Antibiotics (Clotrimazole, Rifampicin)
- •Antihypertensives (Nifedipine, Spironolactone)
- •Antiretroviral drugs (Ritononavir, Saquinavir)
- •Endocrine drugs (Cyproterone acetate)
- •Glucocorticoids
- •Bisphosphonate
- •Calcium supplement
研究组 & 干预措施
Group A0
Vitamin D3 deficient ACO patients with placebo at day 0.
干预措施: placebo (Other)
Group A90
Vitamin D3 deficient ACO patients with placebo at day 90.
干预措施: placebo (Other)
Group B0
Vitamin D3 deficient ACO patients with vitamin D3 at day 0.
干预措施: Vitamin D capsule (Other)
Group B90
Vitamin D3 deficient ACO patients with vitamin D3 at day 90.
干预措施: Vitamin D capsule (Other)
结局指标
主要结局
Ratio of Low frequency to High Frequency (HF) power in frequency domain parameters of heart rate variability
时间窗: Change from Baseline Ratio of Low frequency to High Frequency (HF) power in frequency domain parameters of heart rate variability at 90 days
Ratio of Low frequency to High Frequency (HF) power in frequency domain parameters of heart rate variability was measured at day 0 and after 90 days of vitamin D and placebo administration in vitamin D and in placebo group respectively
High Frequency (HF) power (absolute) in frequency domain parameters of heart rate variability
时间窗: Change from Baseline High Frequency (HF) power (absolute) in frequency domain parameters of heart rate variability at 90days
High Frequency (HF) power (absolute) in frequency domain parameters of heart rate variability was measured at day 0 and after 90 days of vitamin D and placebo administration in vitamin D and in placebo group respectively
Square root of the mean squared differences of successive RR interval (RMSSD) in milliseconds
时间窗: Change from Baseline Square root of the mean squared differences of successive RR interval (RMSSD) at 90 days
Square root of the mean squared differences of successive RR interval (RMSSD) was measured at day 0 and after 90 days of vitamin D and placebo administration in vitamin D and in placebo group respectively
Low Frequency (LF) power in normalised units (n.u) in frequency domain parameters of heart rate variability
时间窗: Change from Baseline Low Frequency (LF) power in normalised units (n.u) in frequency domain parameters of heart rate variability at 90 days
Low Frequency (LF) power in normalised units (n.u) in frequency domain parameters of heart rate variability was measured at day 0 and after 90 days of vitamin D and placebo administration in vitamin D and in placebo group respectively
Mean Heart Rate in beats/min
时间窗: Change from Baseline Mean Heart Rate at 90 days
Mean Heart Rate was measured at day 0 and after 90 days of vitamin D and placebo administration in vitamin D and in placebo group respectively
Standard deviation of successive RR interval differences between adjacent RR intervals (SDSD) in milliseconds
时间窗: Change from Baseline Standard deviation of successive RR interval differences between adjacent RR intervals (SDSD) at 90 dayss
Standard deviation of successive RR interval differences between adjacent RR intervals (SDSD) was measured at day 0 and after 90 days of vitamin D and placebo administration in vitamin D and in placebo group respectively
Number of RR interval differing by >50 milliseconds from adjacent intervals divided by the total number of all RR intervals (pRR50%) in %
时间窗: Change from Baseline Number of RR interval differing by >50 milliseconds from adjacent intervals divided by the total number of all RR intervals (pRR50%) at 90 days
Number of RR interval differing by \>50 milliseconds from adjacent intervals divided by the total number of all RR intervals (pRR50%) was measured at day 0 and after 90 days of vitamin D and placebo administration in vitamin D and in placebo group respectively
vitamin D concentration
时间窗: Change from Baseline Serum vitamin D level at 90 days
serum vitamin D level was measured at day 0 and after 90 days of vitamin D and placebo administration in vitamin D and in placebo group respectively
Mean R-R interval in milliseconds
时间窗: Change from Baseline Mean R-R interval at 90 days
Mean R-R interval was measured at day 0 and after 90 days of vitamin D and placebo administration in vitamin D and in placebo group respectively
Standard deviation of RR interval (SDRR) in milliseconds
时间窗: Change from Baseline Standard deviation of RR interval (SDRR) at 90 days
Standard deviation of RR interval (SDRR) was measured at day 0 and after 90 days of vitamin D and placebo administration in vitamin D and in placebo group respectively
Coefficient of variation of all the R-R interval (CVRR)
时间窗: Change from Baseline Coefficient of variation of all the R-R interval (CVRR) at 90 days
Coefficient of variation of all the R-R interval (CVRR) was measured at day 0 and after 90 days of vitamin D and placebo administration in vitamin D and in placebo group respectively
Total power (absolute) in frequency domain parameters of heart rate variability
时间窗: Change from Baseline Total power (absolute) in frequency domain parameters of heart rate variability at 90 months
Total power (absolute) in frequency domain parameters of heart rate variability was measured at day 0 and after 90 days of vitamin D and placebo administration in vitamin D and in placebo group respectively
High Frequency (HF) power in normalised units (n.u) in frequency domain parameters of heart rate variability
时间窗: Change from Baseline High Frequency (HF) power in normalised units (n.u) in frequency domain parameters of heart rate variability at 90 days
High Frequency (HF) power in normalised units (n.u) in frequency domain parameters of heart rate variability was measured at day 0 and after 90 days of vitamin D and placebo administration in vitamin D and in placebo group respectively
Low Frequency (LF) power (absolute) in frequency domain parameters of heart rate variability
时间窗: Change from Baseline Low Frequency (LF) power (absolute) in frequency domain parameters of heart rate variability at 90 days
Low Frequency (LF) power (absolute) in frequency domain parameters of heart rate variability was measured at day 0 and after 90 days of vitamin D and placebo administration in vitamin D and in placebo group respectively
次要结局
未报告次要终点
研究者
Salsa Bil Nahar
Resident
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh