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

NCT02824237 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-02-08

No results posted yet for this study

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)

Conditions

Interventions

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

Sponsors & Collaborators

  • Fogarty International Center of the National Institute of Health

    collaborator NIH
  • National Institute of Environmental Health Sciences (NIEHS)

    collaborator NIH
  • University of Chicago

    collaborator OTHER
  • York University

    collaborator OTHER
  • UChicago Research, Bangladesh

    collaborator UNKNOWN
  • Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    collaborator OTHER
  • Bangladesh Atomic Energy commission

    collaborator UNKNOWN
  • International Centre for Diarrhoeal Disease Research, Bangladesh

    lead OTHER

Principal Investigators

  • Mohammad Yunus, MBBS, MSc. · International Centre for Diarrhoeal Disease Research, Bangladesh

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Bangladesh

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02824237 on ClinicalTrials.gov