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

Primary Purpose

Household Air Polution, Cardiovascular Diseases, Lung Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Improved cook stove
Sponsored by
International Centre for Diarrhoeal Disease Research, Bangladesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Household Air Polution

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)FemaleAccepts 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.

Sites / Locations

  • International Centre for Diarrhoeal Disease Research, BangladeshRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Improved cook stove

Arm Description

The investigators will conduct a pre-post intervention study to evaluate effectiveness of improved stoves and compare outcomes after two years

Outcomes

Primary Outcome Measures

PM2.5
The investigators will measure pre and post Changes in particulate matter <2.5 micrometers exposure (PM2.5) through 24-hour personal monitoring
CO
The investigators will measure pre and post Changes in carbon monoxide (CO) exposure through 24-hour personal monitors
FEV1
The investigators will measure pre post changes in Forced Expiratory Volume in 1 second (FEV1) by spirometry
FVC
The investigators will measure pre post changes in Forced Vital Capacity (FVC) by spirometry
FEV1/FVC
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)
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)]
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) ]
Vascular stiffness will be measured by brachial artery distensibility (BAD) and pre post intervention changes will be compared
Biomarkers of immune dysfunction and inflammation
Pre and post intervention changes of activation status of macrophages, dendritic cells and T-cell proliferation will be compared

Secondary Outcome Measures

Full Information

First Posted
June 28, 2016
Last Updated
February 6, 2022
Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
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
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1. Study Identification

Unique Protocol Identification Number
NCT02824237
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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) Stable biomarkers of immune function and inflammation are associated with exposure level of HAP. 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Household Air Polution, Cardiovascular Diseases, Lung Diseases, Immune Dysfunction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Improved cook stove
Arm Type
Experimental
Arm Description
The investigators will conduct a pre-post intervention study to evaluate effectiveness of improved stoves and compare outcomes after two years
Intervention Type
Device
Intervention Name(s)
Improved cook stove
Intervention Description
The investigators will conduct a pre-post intervention study to evaluate effectiveness of improved stoves and compare outcomes after two years
Primary Outcome Measure Information:
Title
PM2.5
Description
The investigators will measure pre and post Changes in particulate matter <2.5 micrometers exposure (PM2.5) through 24-hour personal monitoring
Time Frame
Two Years
Title
CO
Description
The investigators will measure pre and post Changes in carbon monoxide (CO) exposure through 24-hour personal monitors
Time Frame
Two Years
Title
FEV1
Description
The investigators will measure pre post changes in Forced Expiratory Volume in 1 second (FEV1) by spirometry
Time Frame
Two Years
Title
FVC
Description
The investigators will measure pre post changes in Forced Vital Capacity (FVC) by spirometry
Time Frame
Two Years
Title
FEV1/FVC
Description
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
Time Frame
Two Years
Title
Reactive hyperemia-peripheral arterial tonometry (RH-PAT) (Endothelial dysfunction)
Description
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
Time Frame
Two Years
Title
Atherosclerosis [carotid intima-media thickness (cIMT)]
Description
Atherosclerosis will be measured by ultrasound-assessed carotid intima-media thickness (cIMT) pre post intervention changes will be assessed
Time Frame
Two Years
Title
Vascular stiffness [brachial artery distensibility (BAD) ]
Description
Vascular stiffness will be measured by brachial artery distensibility (BAD) and pre post intervention changes will be compared
Time Frame
Two Years
Title
Biomarkers of immune dysfunction and inflammation
Description
Pre and post intervention changes of activation status of macrophages, dendritic cells and T-cell proliferation will be compared
Time Frame
Two Years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammad Yunus, MBBS, MSc.
Phone
008801713093872
Email
myunus@icddrb.org
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad AH Chowdhury, MBBS, MPH
Phone
008801730357685
Email
asheq.haider@icddrb.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Yunus, MBBS, MSc.
Organizational Affiliation
International Centre for Diarrhoeal Disease Research, Bangladesh
Official's Role
Principal Investigator
Facility Information:
Facility Name
International Centre for Diarrhoeal Disease Research, Bangladesh
City
Dhaka
ZIP/Postal Code
1212
Country
Bangladesh
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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