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

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ClinicalTrials.gov Identifier: NCT02824237
Recruitment Status : Recruiting
First Posted : July 6, 2016
Last Update Posted : February 12, 2021
Sponsor:
Collaborators:
Fogarty International Center of the National Institute of Health
National Institute of Environmental Health Sciences (NIEHS)
University of Chicago
York University
UChicago Research, Bangladesh
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Bangladesh Atomic Energy commission
Information provided by (Responsible Party):
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)


Condition or disease Intervention/treatment Phase
Household Air Polution Cardiovascular Diseases Lung Diseases Immune Dysfunction Device: Improved cook stove Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Air Pollution

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




Primary Outcome Measures :
  1. PM2.5 [ Time Frame: Two Years ]
    The investigators will measure pre and post Changes in particulate matter <2.5 micrometers exposure (PM2.5) through 24-hour personal monitoring

  2. CO [ Time Frame: Two Years ]
    The investigators will measure pre and post Changes in carbon monoxide (CO) exposure through 24-hour personal monitors

  3. FEV1 [ Time Frame: Two Years ]
    The investigators will measure pre post changes in Forced Expiratory Volume in 1 second (FEV1) by spirometry

  4. FVC [ Time Frame: Two Years ]
    The investigators will measure pre post changes in Forced Vital Capacity (FVC) by spirometry

  5. FEV1/FVC [ Time Frame: Two 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

  6. Reactive hyperemia-peripheral arterial tonometry (RH-PAT) (Endothelial dysfunction) [ Time Frame: 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

  7. Atherosclerosis [carotid intima-media thickness (cIMT)] [ Time Frame: Two Years ]
    Atherosclerosis will be measured by ultrasound-assessed carotid intima-media thickness (cIMT) pre post intervention changes will be assessed

  8. Vascular stiffness [brachial artery distensibility (BAD) ] [ Time Frame: Two Years ]
    Vascular stiffness will be measured by brachial artery distensibility (BAD) and pre post intervention changes will be compared

  9. Biomarkers of immune dysfunction and inflammation [ Time Frame: Two Years ]
    Pre and post intervention changes of activation status of macrophages, dendritic cells and T-cell proliferation will be compared



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824237


Contacts
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Contact: Mohammad Yunus, MBBS, MSc. 008801713093872 myunus@icddrb.org
Contact: Muhammad AH Chowdhury, MBBS, MPH 008801730357685 asheq.haider@icddrb.org

Locations
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Bangladesh
International Centre for Diarrhoeal Disease Research, Bangladesh Recruiting
Dhaka, Bangladesh, 1212
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Fogarty International Center of the National Institute of Health
National Institute of Environmental Health Sciences (NIEHS)
University of Chicago
York University
UChicago Research, Bangladesh
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Bangladesh Atomic Energy commission
Investigators
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Principal Investigator: Mohammad Yunus, MBBS, MSc. International Centre for Diarrhoeal Disease Research, Bangladesh
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Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT02824237    
Other Study ID Numbers: PR-15111
1U01TW010120-01 ( U.S. NIH Grant/Contract )
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: February 12, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Cardiovascular Diseases
Immune System Diseases
Respiratory Tract Diseases