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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 February 2022 |
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Main ID: |
NCT02824237 |
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Date of registration:
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28/06/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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GEOHealth Hub: Household Air Pollution and Cardio-pulmonary and Immune Function Outcomes
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Scientific title:
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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 |
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Date of first enrolment:
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October 1, 2017 |
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Target sample size:
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200 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02824237 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Bangladesh
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Contacts
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Name:
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Mohammad Yunus, MBBS, MSc. |
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Address:
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Telephone:
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Email:
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Affiliation:
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International Centre for Diarrhoeal Disease Research, Bangladesh |
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Name:
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Mohammad Yunus, MBBS, MSc. |
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Address:
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Telephone:
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008801713093872 |
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Email:
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myunus@icddrb.org |
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Affiliation:
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Key inclusion & exclusion 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.
Age minimum:
25 Years
Age maximum:
65 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Cardiovascular Diseases
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Lung Diseases
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Household Air Polution
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Immune Dysfunction
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Intervention(s)
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Device: Improved cook stove
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Primary Outcome(s)
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CO
[Time Frame: Two Years]
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FEV1/FVC
[Time Frame: Two Years]
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FVC
[Time Frame: Two Years]
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PM2.5
[Time Frame: Two Years]
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Biomarkers of immune dysfunction and inflammation
[Time Frame: Two Years]
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Vascular stiffness [brachial artery distensibility (BAD) ]
[Time Frame: Two Years]
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FEV1
[Time Frame: Two Years]
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Atherosclerosis [carotid intima-media thickness (cIMT)]
[Time Frame: Two Years]
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Reactive hyperemia-peripheral arterial tonometry (RH-PAT) (Endothelial dysfunction)
[Time Frame: Two Years]
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Secondary ID(s)
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1U01TW010120-01
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PR-15111
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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