Clinical trial NCT02824237: GEOHealth Hub: Household Air Pollution and Cardio-pulmonary and Immune Function Outcomes
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Household Air Polution
Cardiovascular Diseases
Lung Diseases
Immune Dysfunction
Lead sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
name: National Institute of Environmental Health Sciences (NIEHS)
name: University of Chicago
name: York University
name: UChicago Research, Bangladesh
name: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
name: Bangladesh Atomic Energy commission
First posted: 2016-07-06
Enrollment: 200
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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)


Eligibility criteria: 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.

Primary outcomes:
measure: PM2.5
timeFrame: Two Years
measure: CO
timeFrame: Two Years
measure: FEV1
timeFrame: Two Years
measure: FVC
timeFrame: Two Years
measure: FEV1/FVC
timeFrame: Two Years
measure: Reactive hyperemia-peripheral arterial tonometry (RH-PAT) (Endothelial dysfunction)
timeFrame: Two Years
measure: Atherosclerosis [carotid intima-media thickness (cIMT)]
timeFrame: Two Years
measure: Vascular stiffness [brachial artery distensibility (BAD) ]
timeFrame: Two Years
measure: Biomarkers of immune dysfunction and inflammation
timeFrame: Two Years
Secondary outcomes:
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: International Centre for Diarrhoeal Disease Research, Bangladesh
Study officials:
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Mohammad Yunus, MBBS, MSc.
role: PRINCIPAL_INVESTIGATOR
References: