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

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

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)

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Lung Diseases; Immune Dysfunction; Household Air Polution
• Intervention / Treatment: Device: Improved cook stove

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohammad Yunus, MBBS, MSc.; Phone Number: 008801713093872; Email: myunus@icddrb.org
• Study Contact Backup: Name: Muhammad AH Chowdhury, MBBS, MPH; Phone Number: 008801730357685; Email: asheq.haider@icddrb.org

Study Locations

• Bangladesh
  • Dhaka, Bangladesh, 1212
    • Recruiting
    • International Centre for Diarrhoeal Disease Research, Bangladesh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Improved cook stove; The investigators will conduct a pre-post intervention study to evaluate effectiveness of improved stoves and compare outcomes after two years	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
CO	The investigators will measure pre and post Changes in carbon monoxide (CO) exposure through 24-hour personal monitors	Two Years
FEV1	The investigators will measure pre post changes in Forced Expiratory Volume in 1 second (FEV1) by spirometry	Two Years
FVC	The investigators will measure pre post changes in Forced Vital Capacity (FVC) by spirometry	Two Years
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
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
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
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
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

Collaborators and Investigators

• Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
• Collaborators: University of Chicago; National Institute of Environmental Health Sciences (NIEHS); Fogarty International Center of the National Institute of Health; Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh; York University; UChicago Research, Bangladesh; Bangladesh Atomic Energy commission
• Investigators: Principal Investigator: Mohammad Yunus, MBBS, MSc., International Centre for Diarrhoeal Disease Research, Bangladesh

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: June 28, 2016
• First Submitted That Met QC Criteria: June 30, 2016
• First Posted (Estimate): July 6, 2016

Study Record Updates

• Last Update Posted (Actual): February 8, 2022
• Last Update Submitted That Met QC Criteria: February 6, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Cardiovascular Diseases; Lung Diseases; Immune System Diseases
• Other Study ID Numbers: PR-15111; 1U01TW010120-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data collected of the proposed study will be made fully available to any bonafide researcher. In general, the investigators will follow the data sharing plan developed and practiced by the NIH-funded grantees. Any data request by external researchers will be reviewed by the PIs and the AOC and the requested specific data will be made available to the through a secured web-based interface developed specifically for this project. In general, data will be made available six months after the manuscript reporting results from those specific sets of data are accepted for publication and all data requests will be processed within six months from the receipt of the request in writing. Any data requests with potential conflicts will be reviewed and decided by the AOC.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No