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

Not Applicable
Conditions
Household Air Polution
Cardiovascular Diseases
Lung Diseases
Immune Dysfunction
Interventions
Device: Improved cook stove
Registration Number
NCT02824237
Lead Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
Brief 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)

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
200
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Improved cook stoveImproved cook stoveThe investigators will conduct a pre-post intervention study to evaluate effectiveness of improved stoves and compare outcomes after two years
Primary Outcome Measures
NameTimeMethod
PM2.5Two Years

The investigators will measure pre and post Changes in particulate matter \<2.5 micrometers exposure (PM2.5) through 24-hour personal monitoring

COTwo Years

The investigators will measure pre and post Changes in carbon monoxide (CO) exposure through 24-hour personal monitors

FEV1Two Years

The investigators will measure pre post changes in Forced Expiratory Volume in 1 second (FEV1) by spirometry

FVCTwo Years

The investigators will measure pre post changes in Forced Vital Capacity (FVC) by spirometry

FEV1/FVCTwo Years

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

Reactive hyperemia-peripheral arterial tonometry (RH-PAT) (Endothelial dysfunction)Two Years

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

Atherosclerosis [carotid intima-media thickness (cIMT)]Two Years

Atherosclerosis will be measured by ultrasound-assessed carotid intima-media thickness (cIMT) pre post intervention changes will be assessed

Vascular stiffness [brachial artery distensibility (BAD) ]Two Years

Vascular stiffness will be measured by brachial artery distensibility (BAD) and pre post intervention changes will be compared

Biomarkers of immune dysfunction and inflammationTwo Years

Pre and post intervention changes of activation status of macrophages, dendritic cells and T-cell proliferation will be compared

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

International Centre for Diarrhoeal Disease Research, Bangladesh

🇧🇩

Dhaka, Bangladesh

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