search
Back to results

Bangladesh Vitamin E and Selenium Trial (BEST)

Primary Purpose

Non-melanoma Skin Cancer

Status
Completed
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Selenium
vitamin E
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Non-melanoma Skin Cancer

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Columbia University Arsenic Research Project
  • ICDDR,B

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

1

2

3

Arm 4

Arm Description

Selenium

Vitamin E

Vitamin E + Selenium

Outcomes

Primary Outcome Measures

Skin Cancer

Secondary Outcome Measures

Mortality
Diabetes

Full Information

First Posted
October 24, 2006
Last Updated
April 24, 2023
Sponsor
University of Chicago
Collaborators
Columbia University, Dartmouth-Hitchcock Medical Center, International Centre for Diarrhoeal Disease Research, Bangladesh
search

1. Study Identification

Unique Protocol Identification Number
NCT00392561
Brief Title
Bangladesh Vitamin E and Selenium Trial
Acronym
BEST
Official Title
Bangladesh Vitamin E and Selenium Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2006 (Actual)
Primary Completion Date
August 19, 2021 (Actual)
Study Completion Date
August 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
Columbia University, Dartmouth-Hitchcock Medical Center, International Centre for Diarrhoeal Disease Research, Bangladesh

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate whether selenium and/or vitamin E are effective in preventing non-melanoma skin cancers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-melanoma Skin Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
7000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Selenium
Arm Title
2
Arm Type
Experimental
Arm Description
Vitamin E
Arm Title
3
Arm Type
Experimental
Arm Description
Vitamin E + Selenium
Arm Title
Arm 4
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Selenium
Intervention Description
200 ug Selenium daily
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin E
Intervention Description
100 mg Vitamin E daily
Primary Outcome Measure Information:
Title
Skin Cancer
Time Frame
Incidence during the 6-year study period
Secondary Outcome Measure Information:
Title
Mortality
Time Frame
Occurrence during the 6-year study period
Title
Diabetes
Time Frame
Incidence within 6-year study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Habibul Ahsan, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Arsenic Research Project
City
Dhaka
Country
Bangladesh
Facility Name
ICDDR,B
City
Dhaka
Country
Bangladesh

12. IPD Sharing Statement

Learn more about this trial

Bangladesh Vitamin E and Selenium Trial

We'll reach out to this number within 24 hrs