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

NCT ID: NCT02824237

Last Updated: 2022-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2022-12-31

Brief Summary

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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)

Detailed Description

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Conditions

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Household Air Polution Cardiovascular Diseases Lung Diseases Immune Dysfunction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Improved cook stove

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

Group Type EXPERIMENTAL

Improved cook stove

Intervention Type DEVICE

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

Interventions

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Improved cook stove

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fogarty International Center of the National Institute of Health

NIH

Sponsor Role collaborator

National Institute of Environmental Health Sciences (NIEHS)

NIH

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role collaborator

York University

OTHER

Sponsor Role collaborator

UChicago Research, Bangladesh

UNKNOWN

Sponsor Role collaborator

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

OTHER

Sponsor Role collaborator

Bangladesh Atomic Energy commission

UNKNOWN

Sponsor Role collaborator

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohammad Yunus, MBBS, MSc.

Role: PRINCIPAL_INVESTIGATOR

International Centre for Diarrhoeal Disease Research, Bangladesh

Locations

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International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, , Bangladesh

Site Status RECRUITING

Countries

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Bangladesh

Central Contacts

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Mohammad Yunus, MBBS, MSc.

Role: CONTACT

008801713093872

Muhammad AH Chowdhury, MBBS, MPH

Role: CONTACT

008801730357685

References

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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.

Reference Type DERIVED
PMID: 37579572 (View on PubMed)

Other Identifiers

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1U01TW010120-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PR-15111

Identifier Type: -

Identifier Source: org_study_id

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