Vitamin D Deficiency Clinical Trial
— COPDOfficial title:
Impact of Vitamin D3 Administration on Cardiac Autonomic Tone in Asthma COPD Overlap(ACO) Patients: A Blinded Randomized Control Trial
Verified date | December 2018 |
Source | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 50 |
Est. completion date | August 31, 2018 |
Est. primary completion date | June 30, 2018 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion Criteria: - • 40-80 years of age - Male - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Bangladesh | Dr Sultana Ferdousi | Dhaka |
Lead Sponsor | Collaborator |
---|---|
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
Bangladesh,
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* Note: There are 24 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | vitamin D concentration | 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 | Change from Baseline Serum vitamin D level at 90 days | |
Primary | Mean R-R interval in milliseconds | 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 | Change from Baseline Mean R-R interval at 90 days | |
Primary | Mean Heart Rate in beats/min | 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 | Change from Baseline Mean Heart Rate at 90 days | |
Primary | Standard deviation of RR interval (SDRR) in milliseconds | 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 | Change from Baseline Standard deviation of RR interval (SDRR) at 90 days | |
Primary | Coefficient of variation of all the R-R interval (CVRR) | 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 | Change from Baseline Coefficient of variation of all the R-R interval (CVRR) at 90 days | |
Primary | Square root of the mean squared differences of successive RR interval (RMSSD) in milliseconds | 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 | Change from Baseline Square root of the mean squared differences of successive RR interval (RMSSD) at 90 days | |
Primary | Standard deviation of successive RR interval differences between adjacent RR intervals (SDSD) in milliseconds | 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 | Change from Baseline Standard deviation of successive RR interval differences between adjacent RR intervals (SDSD) at 90 dayss | |
Primary | Number of RR interval differing by >50 milliseconds from adjacent intervals divided by the total number of all RR intervals (pRR50%) in % | 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 | 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 | |
Primary | Total power (absolute) in frequency domain parameters of heart rate variability | 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 | Change from Baseline Total power (absolute) in frequency domain parameters of heart rate variability at 90 months | |
Primary | Low Frequency (LF) power (absolute) in frequency domain parameters of heart rate variability | 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 | Change from Baseline Low Frequency (LF) power (absolute) in frequency domain parameters of heart rate variability at 90 days | |
Primary | High Frequency (HF) power (absolute) in frequency domain parameters of heart rate variability | 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 | Change from Baseline High Frequency (HF) power (absolute) in frequency domain parameters of heart rate variability at 90days | |
Primary | Low Frequency (LF) power in normalised units (n.u) in frequency domain parameters of heart rate variability | 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 | Change from Baseline Low Frequency (LF) power in normalised units (n.u) in frequency domain parameters of heart rate variability at 90 days | |
Primary | High Frequency (HF) power in normalised units (n.u) in frequency domain parameters of heart rate variability | 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 | Change from Baseline High Frequency (HF) power in normalised units (n.u) in frequency domain parameters of heart rate variability at 90 days | |
Primary | Ratio of Low frequency to High Frequency (HF) power in frequency domain parameters of heart rate variability | 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 | Change from Baseline Ratio of Low frequency to High Frequency (HF) power in frequency domain parameters of heart rate variability at 90 days |
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