CompletedPhase 1/2

Selenium and Arsenic Pharmacodynamics

Bangladesh40 participantsStarted 2015-02-10

Plain-language summary

This clinical trial should prove that selenium can treat arsenic exposure in humans by promoting excretion. The new trial differs from previous trials in that participants will be maintained in a local clinic and provided with food and water from their home villages. The purpose of this study to determine the fate of selenium supplements in feces, urine and blood of volunteers living in conditions of high arsenic load in drinking water. The use of a clinic will enable monitoring of all intake and excretion of both arsenic and selenium, and will ensure that participants take their selenium doses or placebo as appropriate. This proof of concept is absolutely essential groundwork for any remediation strategy involving selenium supplements.

Who can participate

Age range

18 Years – 65 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. healthy adult (18-65 years of age) male Bangladeshi volunteers from Laksam Upazila,
. who are exposed to arsenic through their normal source of drinking water;
. who are otherwise healthy except that show some signs of chronic arsenic toxicity (arsenicosis);
. have not consumed selenium-containing supplements with last 6 months;
. not concurrently participating or have participated in any other clinical trial within at least 30 days of registration to the current trial.

Exclusion criteria

. Recent history of consuming selenium, concurrent participation or recent participation in any other clinical trial within at least 30 days of registration to the current trial, and people who recently moved in the area.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Blood As and Se concentrations and chemistry

Timeframe: 10 days

Urinary As and Se concentrations and chemistry

Timeframe: 10 days

Fecal As and Se concentrations and chemistry

Timeframe: 10 days

Trial details

NCT IDNCT02377635

SponsorUniversity of Saskatchewan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-12-19

View on ClinicalTrials.gov More Arsenic Poisoning Chronic trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. healthy adult (18-65 years of age) male Bangladeshi volunteers from Laksam Upazila,
. who are exposed to arsenic through their normal source of drinking water;
. who are otherwise healthy except that show some signs of chronic arsenic toxicity (arsenicosis);
. have not consumed selenium-containing supplements with last 6 months;
. not concurrently participating or have participated in any other clinical trial within at least 30 days of registration to the current trial.

Exclusion criteria

. Recent history of consuming selenium, concurrent participation or recent participation in any other clinical trial within at least 30 days of registration to the current trial, and people who recently moved in the area.