Bangladesh Vitamin E and Selenium Trial (BEST)

April 24, 2023 updated by: University of Chicago
The purpose of this study is to evaluate whether selenium and/or vitamin E are effective in preventing non-melanoma skin cancers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh
        • Icddr,b
      • Dhaka, Bangladesh
        • Columbia University Arsenic Research Project

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Manifest arsenic skin lesions (melanosis, leucomelanosis, or keratosis)
  • Aged 25 to 65 years
  • Permanent resident of study area

Exclusion Criteria:

  • Pregnancy
  • Clinically too ill (enlarged spleen or liver)
  • Presence of gangrene
  • Cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Arm 4
Experimental: 1
Selenium
Dietary supplement: Selenium
200 ug Selenium daily
Experimental: 2
Vitamin E
Dietary supplement: vitamin E
100 mg Vitamin E daily
Experimental: 3
Vitamin E + Selenium
Dietary supplement: Selenium
200 ug Selenium daily
Dietary supplement: vitamin E
100 mg Vitamin E daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Skin Cancer
Time Frame: Incidence during the 6-year study period
Incidence during the 6-year study period

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: Occurrence during the 6-year study period
Occurrence during the 6-year study period
Diabetes
Time Frame: Incidence within 6-year study period
Incidence within 6-year study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

Columbia University
Dartmouth-Hitchcock Medical Center
International Centre for Diarrhoeal Disease Research, Bangladesh

Investigators

  • Principal Investigator: Habibul Ahsan, MD, University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2006

Primary Completion (Actual)

August 19, 2021

Study Completion (Actual)

August 19, 2021

Study Registration Dates

First Submitted

October 24, 2006

First Submitted That Met QC Criteria

October 24, 2006

First Posted (Estimate)

October 26, 2006

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 24, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15091A (R01-CA10743-1)
  • AAAB2309 (Other Identifier: CUMC IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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