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NCT00392561 Clinical Trial

Bangladesh Vitamin E and Selenium Trial

Non-melanoma Skin Cancer Clinical Trial

— BEST  

Official title:
Bangladesh Vitamin E and Selenium Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00392561
Other study ID # 15091A (R01-CA10743-1)
Secondary ID AAAB2309
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2006
Est. completion date August 19, 2021

Study information
Verified date April 2023
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 7000
Est. completion date August 19, 2021
Est. primary completion date August 19, 2021
Accepts healthy volunteers No
Gender All
Age group 25 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Selenium
200 ug Selenium daily
• vitamin E
100 mg Vitamin E daily

Locations
Country Name City State
Bangladesh Columbia University Arsenic Research Project Dhaka
Bangladesh ICDDR,B Dhaka

Sponsors (4)
Lead Sponsor Collaborator
University of Chicago Columbia University, Dartmouth-Hitchcock Medical Center, International Centre for Diarrhoeal Disease Research, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome
Type Measure Description Time frame Safety issue
Primary Skin Cancer Incidence during the 6-year study period
Secondary Mortality Occurrence during the 6-year study period
Secondary Diabetes Incidence within 6-year study period
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