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Impact of Vitamin D3 Administration on Cardiac Autonomic Tone in Asthma Chronic Obstructive Pulmonary Disease(COPD) Overlap Patients (COPD)

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ClinicalTrials.gov Identifier: NCT03773809
Recruitment Status : Completed
First Posted : December 12, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Salsa Bil Nahar, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Asthma-COPD Overlap Syndrome Vitamin D Deficiency Cardiac Autonomic Tone Other: Vitamin D capsule Other: placebo Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Baseline group:

This group will include 60 vitamin D3 deficient ACO patients.

Group A:

Group A0: Vitamin D3 deficient ACO patients with placebo at day 0. Group A90: Vitamin D3 deficient ACO patients with placebo at day 90

Group B:

Group B0: Vitamin D3 deficient ACO patients with vitamin D3 at day 0. Group B90: Vitamin D3 deficient ACO patients with vitamin D3 at day 90.

All the patients will be similar by age, sex and BMI

Masking: Double (Participant, Investigator)
Masking Description: 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.
Primary Purpose: Supportive Care
Official Title: Impact of Vitamin D3 Administration on Cardiac Autonomic Tone in Asthma COPD Overlap(ACO) Patients: A Blinded Randomized Control Trial
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Group A0
Vitamin D3 deficient ACO patients with placebo at day 0.
Other: placebo
oral administration of placebo

Placebo Comparator: Group A90
Vitamin D3 deficient ACO patients with placebo at day 90.
Other: placebo
oral administration of placebo

Active Comparator: Group B0
Vitamin D3 deficient ACO patients with vitamin D3 at day 0.
Other: Vitamin D capsule
The intervention was given by oral administration of vitamin D3 capsule each of which contains 40000 IU of vitamin D3. The capsule was manufactured and supplied by Beximco Pharmaceutical Limited, Bangladesh. The placebo was also be manufactured and supplied by the same pharmaceutical company and was similar in size shape & appearance to vitamin D3 capsule but contained all the ingredients of vitamin D capsule other than the vitamin D3
Other Name: oral administration of Vitamin D capsule

Active Comparator: Group B90
Vitamin D3 deficient ACO patients with vitamin D3 at day 90.
Other: Vitamin D capsule
The intervention was given by oral administration of vitamin D3 capsule each of which contains 40000 IU of vitamin D3. The capsule was manufactured and supplied by Beximco Pharmaceutical Limited, Bangladesh. The placebo was also be manufactured and supplied by the same pharmaceutical company and was similar in size shape & appearance to vitamin D3 capsule but contained all the ingredients of vitamin D capsule other than the vitamin D3
Other Name: oral administration of Vitamin D capsule




Primary Outcome Measures :
  1. vitamin D concentration [ Time Frame: 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

  2. Mean R-R interval in milliseconds [ Time Frame: 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

  3. Mean Heart Rate in beats/min [ Time Frame: 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

  4. Standard deviation of RR interval (SDRR) in milliseconds [ Time Frame: 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

  5. Coefficient of variation of all the R-R interval (CVRR) [ Time Frame: 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

  6. Square root of the mean squared differences of successive RR interval (RMSSD) in milliseconds [ Time Frame: 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

  7. Standard deviation of successive RR interval differences between adjacent RR intervals (SDSD) in milliseconds [ Time Frame: 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

  8. Number of RR interval differing by >50 milliseconds from adjacent intervals divided by the total number of all RR intervals (pRR50%) in % [ Time Frame: 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

  9. Total power (absolute) in frequency domain parameters of heart rate variability [ Time Frame: 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

  10. Low Frequency (LF) power (absolute) in frequency domain parameters of heart rate variability [ Time Frame: 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

  11. High Frequency (HF) power (absolute) in frequency domain parameters of heart rate variability [ Time Frame: 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

  12. Low Frequency (LF) power in normalised units (n.u) in frequency domain parameters of heart rate variability [ Time Frame: 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

  13. High Frequency (HF) power in normalised units (n.u) in frequency domain parameters of heart rate variability [ Time Frame: 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

  14. Ratio of Low frequency to High Frequency (HF) power in frequency domain parameters of heart rate variability [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03773809


Locations
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Bangladesh
Dr Sultana Ferdousi
Dhaka, Bangladesh, 1200
Sponsors and Collaborators
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Investigators
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Study Director: SULTANA FERDOUSI, FERDOUSI Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Publications of Results:
Vitamin D council. I tested my vitamin D level. What do my result mean? 2017 [Internet]. [Cited 2017 Oct 25]. Available from: https://www.vitamindcouncil.org/i-tested-my-vitamin-d-levelwhat-do-result-mean/
Habib GMM, Nahar K, Habib F. Prevalence of Asthma and COPD Overlapping Syndrome (ACOS) in a busy primary care setting of Bangladesh. 1st IPCRG South Asian Scientific Conference: 2017 3-5 Agaust; Colombo. sri Lanka

Other Publications:
Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, [Internet]. c2018. GOLD [updated 201; cited 2018 March 12] Available from: www.ginasthma.org
Global Initiative for Asthma and Global Initiative for Chronic Obstructive Lung Disease. Diagnosis of Diseases of Chronic Airflow Limitation: Asthma, COPD and Asthma-COPD Overlap (ACO) [Internet]. A joint project of GINA and GOLD [updated April 2017; Cited 2017 Nov 12]. Available from: www.msc.es/organizacion/sns/plan CalidadSNS/pdf/GOLD_ACOS_2017.pdf

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Responsible Party: Salsa Bil Nahar, Resident, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
ClinicalTrials.gov Identifier: NCT03773809     History of Changes
Other Study ID Numbers: No. BSMMU/2018/478
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Salsa Bil Nahar, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh:
ACO
HRV
Vitamin D deficiency

Additional relevant MeSH terms:
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Asthma
Pulmonary Disease, Chronic Obstructive
Vitamin D Deficiency
Undifferentiated Connective Tissue Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Connective Tissue Diseases
Autoimmune Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents