This trial is active, not recruiting.

Condition non-melanoma skin cancer
Treatments selenium, vitamin e
Sponsor University of Chicago
Collaborator Columbia University
Start date April 2006
End date June 2018
Trial size 7000 participants
Trial identifier NCT00392561, 15091A (R01-CA10743-1), AAAB2309


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model factorial assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose prevention
200 ug Selenium daily
Vitamin E
vitamin e
100 mg Vitamin E daily
Vitamin E + Selenium
200 ug Selenium daily
vitamin e
100 mg Vitamin E daily
(No Intervention)

Primary Outcomes

Skin Cancer
time frame: Incidence during the 6-year study period

Secondary Outcomes

time frame: Occurrence during the 6-year study period
time frame: Incidence within 6-year study period

Eligibility Criteria

Male or female participants from 25 years up to 65 years old.

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

Additional Information

Official title Bangladesh Vitamin E and Selenium Trial
Principal investigator Habibul Ahsan, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Chicago.