Strong Heart Water Study

Arsenic Poisoning Clinical Trial

— SHWS  

Official title:

Participatory Interventions to Reduce Arsenic Exposure in American Indian Communities

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03725592
• Other study ID #: IRB00006504
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2, 2018
• Est. completion date: May 4, 2025

Study information

• Verified date: June 2024
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Develop and evaluate the effectiveness of multi-level participatory interventions in reducing arsenic exposure among American Indian (AI) communities from North and South Dakota who participated in the Strong Heart Study (SHS).

Description:

Design, implement, and evaluate multi-level participatory interventions that can lead to a sustained reduction in arsenic exposure in adults and children in Cheyenne River, Oglala, and Spirit Lake communities in North/South Dakota by: 1) building local capacity at the tribal and community levels to ensure the long-term sustainability of the interventions. 2) conduct a 2-arm cluster-randomized controlled trial comparing arsenic removal device only to removal device and intensive education and promotion among 300 households, 600 participants.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 57
• Est. completion date: May 4, 2025
• Est. primary completion date: May 4, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years and older

Eligibility

Inclusion Criteria:

• Arsenic levels in household drinking water must be =10 µg/L

• Households must have =1 adult =18 years of age eligible and willing to participate.

• Household must have an active well on the property that is used for drinking water.

• Household must have indoor plumbing and a permanent heat source.

• Participant must plan to reside in the household for the next year, must reside in the residence for =4 days/week, and year round (i.e. all seasons).

• =1 household members must identify as American Indian.

• Household must be willing to grant study members access to the interior of their household for screening and data collection.

Exclusion Criteria:

• Arsenic levels in household drinking water <10 µg/L

• Households with no adult =18 years of age eligible and willing to participate.

• Households without an active well on the property that is used for drinking water (i.e. connected to municipal water supply).

• Households without indoor plumbing and/or a permanent heat source.

• Participant planning to reside in the household <1 year, residing in the residence for <4 days/week, or not year round (i.e. not during all seasons).

• No household member identifies as American Indian.

• Household unwilling to grant study members access to the interior of their household for screening and data collection.

Related Conditions & MeSH terms

• Arsenic Poisoning
• Poisoning

Intervention

Other:
• Standard Treatment
Participant households receive a point of use arsenic removal device and a replacement filter. Households are also provided with an instruction manual on how to use the device.

Behavioral:
• Intensive Education
Participant households receive up to five additional in-person visits and phone calls to provide support regarding the health implications of arsenic and the proper use and maintenance of the arsenic removal device.

Locations

Country	Name	City	State
United States	Johns Hopkins Bloomberg School of Public Health, ICTR	Baltimore	Maryland

Sponsors (4)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Columbia University, Missouri Breaks Industries Research, Inc., National Institute Of Allergy & Infectuous Disease

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine arsenic concentrations in household members	(1a) urine arsenic concentrations among household members (in parts per billion, µg/L)	6 months post-installation of the arsenic removal device
Secondary	Arsenic concentrations in filtered water	(2a) water arsenic concentrations from arsenic removal device (parts per billion, µg/L)	6 months post-installation of the arsenic removal device
Secondary	Water usage from arsenic removal device	(2b) water usage from removal device (from flow meter, in gallons)	6 months post-installation of the arsenic removal device
Secondary	Biomarkers of cardiovascular disease	(2c) biomarkers of cardiovascular disease (soluble adhesion molecules) in household members	6 months post-installation of the arsenic removal device
Secondary	Biomarkers of diabetes	(2d) biomarkers of diabetes (hemoglobin A1c) in household members	6 months post-installation of the arsenic removal device
Secondary	Biomarkers of pulmonary function	(2e.1) lower forced expiratory volume in 1 second (FEV1) (actual performance in liters of air, percent of predicted values)	6 months post-installation of the arsenic removal device
Secondary	Biomarkers of pulmonary function	(2e.2) lower forced vital capacity (FVC) among household members (actual performance in liters of air, percent of predicted values)	6 months post-installation of the arsenic removal device
Secondary	Blood pressure	(2f) systolic and diastolic blood pressure levels	6 months post-installation of the arsenic removal device
Secondary	Long-term urine arsenic concentrations in household members	(2g) long-term sustainability assessment to evaluate arsenic concentrations in urine among household members (parts per billion, µg/L)	1 year post-installation of the arsenic removal device
Secondary	Long-term functionality of arsenic removal device	(2h) long-term sustainability assessment to evaluate water arsenic concentrations from arsenic removal device (parts per billion, µg/L)	1 year post-installation of the arsenic removal device
Secondary	Long-term water usage from arsenic removal device	(2i) long-term sustainability assessment to evaluate water usage from removal device (from flow meter, in gallons)	1 year post-installation of the arsenic removal device
Secondary	Long-term maintenance of arsenic removal device	(2j) long-term sustainability assessment to evaluate self-reported maintenance of the arsenic removal device (Did household change the device filter when indicated by light on spigot? Does household have replacement filter(s) available for subsequent filter change(s)?)	1 year post-installation of the arsenic removal device