NCT01442727

Brief Summary

Context: Approximately 100 million people throughout the world consume water contaminated with arsenic at levels above carcinogenic thresholds, including 40 million in Bangladesh alone, with up to one-fourth of deaths attributed to arsenic exposure in the worst-affected regions. There are no proven therapies for treating chronic arsenic toxicity or for preventing arsenical cancers. Selenium has been known to counter arsenic toxicity in a variety of animal models. The investigators have recently shown in animals and humans that this effect is mediated by the formation of \[(GS)2AsSe\]- , the seleno-bis(S-glutathionyl) arsinium ion, which is then rapidly excreted via the hepatobiliary system. Concurrently, two Phase II studies in China and Bangladesh have suggested clinical benefit to selenium supplementation in arsenicosis patients. Objective: To assess whether daily selenium supplementation counters arsenic toxicity in patients exposed to drinking water arsenic. If proven effective, selenium supplementation might be safely and cost-effectively implemented in the worst-affected localities.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
819

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Dec 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 28, 2011

Completed
Last Updated

October 7, 2011

Status Verified

October 1, 2011

Enrollment Period

2.3 years

First QC Date

September 22, 2011

Last Update Submit

October 6, 2011

Conditions

Arsenical MelanosisArsenical KeratosisArsenical CancersArsenicosisArsenic ExposureArsenic ToxicityArsenic Poisoning

Keywords

arsenical melanosisarsenical melanosesarsenical keratosisarsenical keratosesarsenical cancerarsenic cancersarsenicarsenicosisarsenic exposurearsenic toxicityarsenic poisoningdrinking waterseleniumselenitesodium selenite

Outcome Measures

Primary Outcomes (1)

  • changes in arsenical melanosis

    Arsenical melanosis was recorded in 4 quadrants of each patients' torsos using the Dermlite epiluminescence microscopy system. The images were then scored in a blinded, randomized fashion by a dermatologist.

    0 weeks (baseline), 24 weeks, and 48 weeks (end)

Secondary Outcomes (2)

  • changes in blood arsenic levels

    week 0, week 24 and week 48

  • changes in urinary arsenic levels

    week 0, week 24 and week 48

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Patients who receive control (placebo)

Drug: placebo

Selenium

ACTIVE COMPARATOR

Patients who receive treatment (selenium)

Drug: sodium selenite

Interventions

sodium seleniteDRUG

200 micrograms (µg) of selenium in the form of sodium selenite; capsule form consumed once daily with breakfast.

Also known as: selenium, selenite
Selenium
placeboDRUG

dicalcium phosphate capsule matching the selenium capsule in appearance; consumed once daily with breakfast

Placebo

Eligibility Criteria

Age12 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Resident of Bangladesh in an arsenic-affected region (Chandpur)
  • Age between 12 and 55
  • Exposure to arsenic in home drinking water greater than 50 ug/L.
  • Arsenical melanosis on the torso confirmed by epiluminescence microscopy

You may not qualify if:

  • Recent history or plans to consume selenium-containing supplements
  • Anticipated change in home drinking water supply during study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SETAC Trial Field Office

Kalibari Town, Chandpur District, Bangladesh

Location

MeSH Terms

Conditions

Arsenic Poisoning

Interventions

Sodium SeleniteSeleniumSelenious Acid

Condition Hierarchy (Ancestors)

Heavy Metal Poisoning, Nervous SystemNeurotoxicity SyndromesNervous System DiseasesPoisoningChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Selenium CompoundsInorganic ChemicalsSodium CompoundsChalcogensElementsMinerals

Study Officials

  • Julian E Spallholz, PhD

    Texas Tech University

    PRINCIPAL INVESTIGATOR

  • Paul F La Porte, PhD

    Pritzker School of Medicine, The University of Chicago

    PRINCIPAL INVESTIGATOR

  • Selim Ahmed, MBBS, FCPS

    Institute of Child & Mother Health, Dhaka, Bangladesh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Nutrition & Biochemistry, Division of Nutritional Sciences, College of Human Sciences, Texas Tech University.

Study Record Dates

First Submitted

September 22, 2011

First Posted

September 28, 2011

Study Start

December 1, 2006

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

October 7, 2011

Record last verified: 2011-10

Locations

BA(1)