NCT02824237

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. 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. 2.Stable biomarkers of immune function and inflammation are associated with exposure level of HAP.
  3. 3.Use of improved cook stove reduces exposure to HAP and thereby improve pre-clinical and molecular measures of cardio-pulmonary and immune functions.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 6, 2016

Completed
1.2 years until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

February 8, 2022

Status Verified

January 1, 2022

Enrollment Period

5.2 years

First QC Date

June 28, 2016

Last Update Submit

February 6, 2022

Conditions

Household Air PolutionCardiovascular DiseasesLung DiseasesImmune Dysfunction

Outcome Measures

Primary Outcomes (9)

  • PM2.5

    The investigators will measure pre and post Changes in particulate matter \<2.5 micrometers exposure (PM2.5) through 24-hour personal monitoring

    Two Years

  • CO

    The investigators will measure pre and post Changes in carbon monoxide (CO) exposure through 24-hour personal monitors

    Two Years

  • FEV1

    The investigators will measure pre post changes in Forced Expiratory Volume in 1 second (FEV1) by spirometry

    Two Years

  • FVC

    The investigators will measure pre post changes in Forced Vital Capacity (FVC) by spirometry

    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

    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

    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

    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

    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

    Two Years

Study Arms (1)

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

Device: Improved cook stove

Interventions

Improved cook stoveDEVICE

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

Improved cook stove

Eligibility Criteria

Age25 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) 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,

You may not qualify if:

  • \) 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, 1212, Bangladesh

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37579572DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesLung DiseasesImmune System Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Mohammad Yunus, MBBS, MSc.

    International Centre for Diarrhoeal Disease Research, Bangladesh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammad Yunus, MBBS, MSc.

CONTACT

008801713093872myunus@icddrb.org

Muhammad AH Chowdhury, MBBS, MPH

CONTACT

008801730357685asheq.haider@icddrb.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2016

First Posted

July 6, 2016

Study Start

October 1, 2017

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

February 8, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

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.

Locations

BA(1)