Household Air PolutionNCT02824237
GEOHealth Hub: Household Air Pollution and Cardio-pulmonary and Immune Function Outcomes
A study testing Improved cook stove in people with Household Air Polution and Cardiovascular Diseases, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial 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). Read more about this study
- Who is it for?
- Ages 25 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Household Air Polution, Cardiovascular Diseases, Lung Diseases
- What is being tested?
- Improved cook stove
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Oct 2017to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Bangladesh1 site, 1 recruiting
- Recruiting
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, 1212
About this study
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
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.
Read more
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)
- Being tested
- Improved cook stove
- Medical subject headings
- Cardiovascular Diseases, Lung Diseases, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improved cook stoveDevice
The investigators will conduct a pre-post intervention study to evaluate effectiveness of improved stoves and compare outcomes after two years
| Study group | Role | What they receive |
|---|---|---|
| Improved cook stove | Experimental | The investigators will conduct a pre-post intervention study to evaluate effectiveness of improved stoves and compare outcomes after two years Receives: Device: Improved cook stove |
What is being measured
The primary outcome is the main question the study is designed to answer.
PM2.5
The investigators will measure pre and post Changes in particulate matter <2.5 micrometers exposure (PM2.5) through 24-hour personal monitoring
Measured: Two Years
CO
The investigators will measure pre and post Changes in carbon monoxide (CO) exposure through 24-hour personal monitors
Measured: Two Years
FEV1
The investigators will measure pre post changes in Forced Expiratory Volume in 1 second (FEV1) by spirometry
Measured: Two Years
FVC
The investigators will measure pre post changes in Forced Vital Capacity (FVC) by spirometry
Measured: Two Years
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
Measured: Two Years
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
Measured: Two Years
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
Measured: Two Years
Vascular stiffness [brachial artery distensibility (BAD) ]
Vascular stiffness will be measured by brachial artery distensibility (BAD) and pre post intervention changes will be compared
Measured: Two Years
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
Measured: Two Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study start1 Oct 2017
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Household Air PolutionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Mohammad Yunus, MBBS, MSc., Principal investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824237
- Sponsor's protocol ID
- PR-15111
- Other IDs
- 1U01TW010120-01
- Status last verified
- Jan 2022
- First submitted
- 28 Jun 2016
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Raqib R, Akhtar E, Ahsanul Haq M, Ahmed S, Haque F, Chowdhury MAH, Shahriar MH, Begum BA, Eunus M, Sarwar G, Parvez F, Sharker Y, Ahsan H, Yunus M. Reduction of household air pollution through clean fuel intervention and recovery of cellular immune balance. Environ Int. 2023 Sep;179:108137. doi: 10.1016/j.envint.2023.108137. Epub 2023 Aug 9.
PubMed 37579572
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02824237
- Acronym / sponsor ID
- PR-15111
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- 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
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 6 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Improved cook stove | Experimental | Device: Improved cook stoveThe investigators will conduct a pre-post intervention study to evaluate effectiveness of improved stoves and compare outcomes after two years |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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,
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Improved cook stoveThe investigators will conduct a pre-post intervention study to evaluate effectiveness of improved stoves and compare outcomes after two years | Device | Improved cook stove |
Primary outcome
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
CO
Time frame: Two Years
The investigators will measure pre and post Changes in carbon monoxide (CO) exposure through 24-hour personal monitors
FEV1
Time frame: Two Years
The investigators will measure pre post changes in Forced Expiratory Volume in 1 second (FEV1) by spirometry
FVC
Time frame: Two Years
The investigators will measure pre post changes in Forced Vital Capacity (FVC) by spirometry
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Derived from this study: PubMed 37579572Raqib R, Akhtar E, Ahsanul Haq M, Ahmed S, Haque F, Chowdhury MAH, Shahriar MH, Begum BA, Eunus M, Sarwar G, Parvez F, Sharker Y, Ahsan H, Yunus M. Reduction of household air pollution through clean fuel intervention and recovery of cellular immune balance. Environ Int. 2023 Sep;179:108137. doi: 10.1016/j.envint.2023.108137. Epub 2023 Aug 9.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad Yunus, MBBS, MSc. principal investigator
International Centre for Diarrhoeal Disease Research, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Improved cook stove in people with Household Air Polution and Cardiovascular Diseases, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammad Yunus, MBBS, MSc. (008801713093872, myunus@icddrb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PM2.5 (time frame: Two Years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02824237, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.