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Intensive Education for Arsenic Poisoning (SHWS Trial)

N/A
Waitlist Available
Led By Christine Marie George, PhD
Research Sponsored by Johns Hopkins Bloomberg School of Public Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post-installation of the arsenic removal device
Awards & highlights

SHWS Trial Summary

This trial will test whether multi-level participatory interventions can reduce exposure to arsenic among American Indian communities in North and South Dakota.

Who is the study for?
The Strong Heart Water Study is for American Indian adults with arsenic levels in their household drinking water of ≥10 µg/L. Participants must be willing to participate, have indoor plumbing and a permanent heat source, plan to stay in the home for at least a year, live there most of the week throughout all seasons, and allow access for data collection.Check my eligibility
What is being tested?
This study aims to assess how effective multi-level interventions are at reducing arsenic exposure among American Indians. It involves comparing standard treatment methods against intensive education programs designed specifically for these communities.See study design
What are the potential side effects?
Since this trial focuses on educational interventions rather than medical treatments or drugs, traditional side effects are not expected. However, participants may experience changes in daily routines or water usage habits.

SHWS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post-installation of the arsenic removal device
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post-installation of the arsenic removal device for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Urine arsenic concentrations in household members
Secondary outcome measures
Arsenic concentrations in filtered water
Biomarkers of cardiovascular disease
Biomarkers of diabetes
+7 more

Side effects data

From 2014 Phase 4 trial • 402 Patients • NCT01396395
3%
Headache
2%
Nausea
1%
Glaucoma
1%
Chest pain
1%
Gastric ulcer
1%
Peripheral edema
1%
Dizziness
1%
Coronary artery disease
1%
Angina
1%
Diabetic foot
1%
Multiple myeloma
1%
Sudden death
1%
Unstable angina
1%
Supraventricular tachycardia
1%
Duodenal ulcer
1%
Chronic renal failure
1%
Increased blood pressure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard Treatment Plus Nicorandil
Standard Treatment

SHWS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intensive EducationExperimental Treatment2 Interventions
Receives the Standard Treatment plus in-person visits and phone calls for follow-up (Community Participatory Arsenic Mitigation)
Group II: Standard TreatmentActive Control1 Intervention
Receives arsenic removal device and written instructions and phone calls on how to use the device (Arsenic Removal Device)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intensive Education
2014
N/A
~20

Find a Location

Who is running the clinical trial?

Columbia UniversityOTHER
1,431 Previous Clinical Trials
2,460,774 Total Patients Enrolled
Missouri Breaks Industries Research, Inc.OTHER
7 Previous Clinical Trials
2,100 Total Patients Enrolled
Johns Hopkins Bloomberg School of Public HealthLead Sponsor
410 Previous Clinical Trials
2,116,873 Total Patients Enrolled

Media Library

Standard Treatment Clinical Trial Eligibility Overview. Trial Name: NCT03725592 — N/A
Arsenic Poisoning Research Study Groups: Standard Treatment, Intensive Education
Arsenic Poisoning Clinical Trial 2023: Standard Treatment Highlights & Side Effects. Trial Name: NCT03725592 — N/A
Standard Treatment 2023 Treatment Timeline for Medical Study. Trial Name: NCT03725592 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Strong Heart Water Study
2018. "Strong Heart Water Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03725592.
~0 spots leftby May 2024
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