Bangladesh Vitamin E and Selenium Trial

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: June 2018

Interventions

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

Arms, Groups and Cohorts

  • Experimental: 1
    • Selenium
  • Experimental: 2
    • Vitamin E
  • Experimental: 3
    • Vitamin E + Selenium
  • No Intervention: Arm 4

Clinical Trial Outcome Measures

Primary Measures

  • Skin Cancer
    • Time Frame: Incidence during the 6-year study period

Secondary Measures

  • Mortality
    • Time Frame: Occurrence during the 6-year study period
  • Diabetes
    • Time Frame: Incidence within 6-year study period

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 25 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Chicago
  • Collaborator
    • Columbia University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Habibul Ahsan, MD, Principal Investigator, University of Chicago

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