Bangladesh Vitamin E and Selenium Trial (BEST)

The University of Chicago

Status: Completed

Conditions: Non-melanoma Skin Cancer

Treatments: Dietary Supplement: vitamin E; Dietary Supplement: Selenium

Study type: Interventional

Funder types: Other

Identifiers

NCT00392561

AAAB2309 (Other Identifier)

15091A (R01-CA10743-1)

Details and patient eligibility

About

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

Enrollment: 7,000 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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7,000 participants in 4 patient groups

1

Experimental group

Description:

Selenium

Treatment:

Dietary Supplement: Selenium

2

Experimental group

Description:

Vitamin E

Treatment:

Dietary Supplement: vitamin E

3

Experimental group

Description:

Vitamin E + Selenium

Treatment:

Dietary Supplement: Selenium

Dietary Supplement: vitamin E

Arm 4

No Intervention group