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

I

International Centre for Diarrhoeal Disease Research (icddr,b)

Status

Unknown

Conditions

Household Air Polution
Lung Diseases
Immune Dysfunction
Cardiovascular Diseases

Treatments

Device: Improved cook stove

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02824237
PR-15111
1U01TW010120-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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)

Enrollment

200 estimated patients

Sex

Female

Ages

25 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

200 participants in 1 patient group

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

Trial contacts and locations

1

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Central trial contact

Mohammad Yunus, MBBS, MSc.; Muhammad AH Chowdhury, MBBS, MPH

Data sourced from clinicaltrials.gov

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