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NCT02377635: SEASP

Selenium and Arsenic Pharmacodynamics

Completed Phase 1, PHASE2 Last updated 30 October 2017
What this trial tests

Phase 1, PHASE2 trial testing Anhydrous selenite in Arsenic Poisoning Chronic in 40 participants. Completed in 19 January 2017.

Timeline
10 February 2015
Primary endpoint
19 December 2016
19 January 2017

Quick facts

Lead sponsorUniversity of Saskatchewan
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposebasic science
Enrollment40
Start date10 February 2015
Primary completion19 December 2016
Estimated completion19 January 2017
Sites1 location across Bangladesh

Drugs / interventions tested

Conditions studied

Sponsor

University of Saskatchewan

Who can join

Adults 18 to 65, male only, with Arsenic Poisoning Chronic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Megaphages infect Prevotella and variants are widespread in gut microbiomes.
    Devoto AE, Santini JM, Olm MR, Anantharaman K, et al · · 2019 · cited 172× · PMID 30692672 · DOI 10.1038/s41564-018-0338-9
  2. Hydrogen-based metabolism as an ancestral trait in lineages sibling to the Cyanobacteria.
    Matheus Carnevali PB, Schulz F, Castelle CJ, Kantor RS, et al · · 2019 · cited 61× · PMID 30692531 · DOI 10.1038/s41467-018-08246-y

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