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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03351504
Other study ID # 2017P000306/PHS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 7, 2018
Est. completion date October 31, 2020

Study information

Verified date December 2020
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates the impact of a solar lighting system on kerosene lamp use, levels of indoor air pollution, and health in women living in rural Uganda. Half of the participants will receive the lighting systems immediately, while the other half will receive them after an 18 month delay.


Description:

One fifth of the global population relies on kerosene lamps for lighting, yet few studies have focused on kerosene lighting as a source of indoor air pollution. In our preliminary studies performed in Uganda, we show that homes using solar lighting have much lower levels of indoor air pollution compared to homes using kerosene lighting. The primary goal of this study is to determine the extent to which solar lighting will reduce kerosene use and indoor air pollution in rural Uganda, whether this intervention improves lung health, and to identify the role bacteria in our gut have on determining whether or not people will get sick from indoor air pollution.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date October 31, 2020
Est. primary completion date October 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Women living in Nyakabare Parish, Uganda with no prior history of chronic lung disease Exclusion Criteria: - Current active tuberculosis in any family member

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Solar lighting system
consisting of a solar panel, rechargeable lead acid battery, charge controller, wiring and switches to 4 lighting points fitted with LED bulbs. This system will include a two-year service warranty.

Locations

Country Name City State
Uganda Mbarara University of Science and Technology Mbarara
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (3)

Lead Sponsor Collaborator
Massachusetts General Hospital Harvard School of Public Health, Mbarara University of Science and Technology

Countries where clinical trial is conducted

United States,  Uganda, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fine particulate matter (PM2.5) and Black Carbon Sampling for PM2.5 and Black Carbon over 48 hours will be collected 48 hour
Secondary Daily use of solar lighting system (hours per day) A current monitory is installed as part of the solar lighting system that measures the hours per day each light switch is turned on baseline, 3 months, 6 months, 12 months after the intervention
Secondary Blood pressure Resting blood pressure baseline, 3 months, 6 months, 12 months after the intervention
Secondary Forced Expiratory Volume in one Second (FEV1) Pre- and Post- bronchodilator spirometry baseline, 3 months, 6 months, 12 months after the intervention
Secondary Heart rate variability Resting 10 minute heart rate variability baseline, 3 months, 6 months, 12 months after the intervention
Secondary Stool microbiome Microbial sequencing of the stool will be performed baseline, 3 months, 6 months, 12 months after the intervention
Secondary Qualitative interviews 1:1 qualitative interviews will be performed with participants Post-intervention
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