GEOHealth Hub: Household Air Pollution and Cardio-pulmonary and Immune Function Outcomes

Cardiovascular Diseases Clinical Trial

Official title:

Bangladesh Center for Global Environmental and Occupational Health: A Study of Effects of Household Air Pollution on Cardio-pulmonary and Immune Function Outcomes Among Nonsmokers and Their Potential Prevention Avenues in Rural Bangladesh

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02824237
• Other study ID #: PR-15111
• Secondary ID: 1U01TW010120-01
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: December 2022

Study information

• Verified date: January 2022
• Source: International Centre for Diarrhoeal Disease Research, Bangladesh
• Contact: Mohammad Yunus, MBBS, MSc.
• Phone: 008801713093872
• Email: myunus[@]icddrb.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background:

The increasing effect of environmental, occupational and climate change poses serious global threat for public health. More than half of the world's population, including around 85% people in Bangladesh, are exposed to household air pollutants (HAP). Environmental consequences of climate change are among the highest. Little evidence is available on the effects HAP on cardiopulmonary outcomes in low-income populations. Same is true for occupational health and climate change. The investigators will evaluate the effects of HAP on cardio-pulmonary and markers of immune function among non-smoking individuals. The investigators will also conduct two pilot studies to explore health effects associated with working in the garments industry and that of temperature due to climate changes.

Hypothesis:

1. Preclinical measures of cardiovascular diseases and pulmonary function are associated with exposure level of house hold air pollution (HAP) (assessed through PM2.5, CO and BC concentrations)

2. Stable biomarkers of immune function and inflammation are associated with exposure level of HAP.

3. Use of improved cook stove reduces exposure to HAP and thereby improve pre-clinical and molecular measures of cardio-pulmonary and immune functions.

Methods: The investigators will conduct a cross sectional study to assess the associations of HAP with preclinical makers of CVD among 600 non-smoking participants aged 25 to 65 years. Biomass exposure will be assessed for PM2.5, carbon Monoxide (CO) and black carbon (BC) by collecting personal air samples for 24-hour. Blood sample will be utilized from a subset of 200 adult participants and 60 children aged 3-5 years for assessing immune markers. The study will be conducted in icddr,b and URB study site at Matlab and Araihazar respectively.

After the cross sectional assessment, the investigators will conduct a pre-post intervention study to evaluate effectiveness of improved stoves in a subset of 200 homes. The investigators will measure the aforementioned markers after two years of cook stove installation. Finally, as pilot studies, health outcomes due to climate change (temperature change) and occupation (garment industry work) will be explored.

Outcome measures:

HAP will be assessed through PM2.5, CO and BC concentrations. Pulmonary function will be assessed through FEV1, FVC and FEV1/FVC. Preclinical makers of CVD will include RH-PAT, FMD, IMT, BAD, EKG and PFT. Markers of Immune function - proliferation of macrophage, dendritic cells (DC), neutrophils and T-cell, as well as macrophage derived cytokines (a panel of 17 or 27 cytokines) in peripheral blood mononuclear cells (PBMC)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

1) aged between 25 and 65, 2) live in biomass using home with traditional stoves, 3) non-smoker and live with non-smokers, 4) exposed to <5 µg/L of water arsenic,

Exclusion Criteria:

1) Any immune related illness or taking any prescription medication (particularly those that suppress or enhance immune function), and 2) any clinical events of CVD or lung disease, including stroke or coronary heart disease.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Household Air Polution
• Immune Dysfunction
• Immune System Diseases
• Lung Diseases

Intervention

Device:
• Improved cook stove
The investigators will conduct a pre-post intervention study to evaluate effectiveness of improved stoves and compare outcomes after two years

Locations

Country	Name	City	State
Bangladesh	International Centre for Diarrhoeal Disease Research, Bangladesh	Dhaka

Sponsors (8)

Lead Sponsor	Collaborator
International Centre for Diarrhoeal Disease Research, Bangladesh	Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh, Bangladesh Atomic Energy commission, Fogarty International Center of the National Institute of Health, National Institute of Environmental Health Sciences (NIEHS), UChicago Research, Bangladesh, University of Chicago, York University

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PM2.5	The investigators will measure pre and post Changes in particulate matter <2.5 micrometers exposure (PM2.5) through 24-hour personal monitoring	Two Years
Primary	CO	The investigators will measure pre and post Changes in carbon monoxide (CO) exposure through 24-hour personal monitors	Two Years
Primary	FEV1	The investigators will measure pre post changes in Forced Expiratory Volume in 1 second (FEV1) by spirometry	Two Years
Primary	FVC	The investigators will measure pre post changes in Forced Vital Capacity (FVC) by spirometry	Two Years
Primary	FEV1/FVC	The investigators will measure pre post changes in the ratio of Forced Expiratory Volume in 1 second and Forced Vital Capacity (FEV1/FVC) by spirometry	Two Years
Primary	Reactive hyperemia-peripheral arterial tonometry (RH-PAT) (Endothelial dysfunction)	Endothelial dysfunction will be measured by reactive hyperemia-peripheral arterial tonometry (RH-PAT) and Pre and post comparison will be done pre post intervention changes will be assessed	Two Years
Primary	Atherosclerosis [carotid intima-media thickness (cIMT)]	Atherosclerosis will be measured by ultrasound-assessed carotid intima-media thickness (cIMT) pre post intervention changes will be assessed	Two Years
Primary	Vascular stiffness [brachial artery distensibility (BAD) ]	Vascular stiffness will be measured by brachial artery distensibility (BAD) and pre post intervention changes will be compared	Two Years
Primary	Biomarkers of immune dysfunction and inflammation	Pre and post intervention changes of activation status of macrophages, dendritic cells and T-cell proliferation will be compared	Two Years