Bangladesh Vitamin E and Selenium Trial

Not Applicable

Completed

• Conditions: Non-melanoma Skin Cancer
• Interventions: Dietary Supplement: Selenium; Dietary Supplement: vitamin E

• Registration Number: NCT00392561
• Lead Sponsor: University of Chicago

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-01
• Study First Submitted: 2006-10-24
• Study First Submitted QC: 2006-10-24
• Study First Posted: 2006-10-26
• Primary Completion: 2021-08-19
• Study Completion: 2021-08-19
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-24
• Last Update Posted: 2023-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7000

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1	Selenium	Selenium
2	vitamin E	Vitamin E
3	Selenium	Vitamin E + Selenium
3	vitamin E	Vitamin E + Selenium

Primary Outcome Measures

Name	Time	Method
Skin Cancer	Incidence during the 6-year study period

Secondary Outcome Measures

Name	Time	Method
Mortality	Occurrence during the 6-year study period
Diabetes	Incidence within 6-year study period

Trial Locations

Locations (2)

Columbia University Arsenic Research Project; 🇧🇩 Dhaka, Bangladesh

ICDDR,B; 🇧🇩 Dhaka, Bangladesh