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

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

Conditions

• Asthma-COPD Overlap Syndrome
• Vitamin D Deficiency
• Cardiac Autonomic Tone

Interventions

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

placebo

oral administration of placebo

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  lead OTHER

Principal Investigators

• SULTANA FERDOUSI, FERDOUSI · Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

80 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-08-01

Primary Completion

2018-06-30

Completion

2018-08-31

Countries

• Bangladesh

Study Locations