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Bangladesh Vitamin E and Selenium Trial (BEST)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Columbia University
Dartmouth-Hitchcock Medical Center
International Centre for Diarrhoeal Disease Research, Bangladesh
Information provided by (Responsible Party):
Habibul Ahsan, University of Chicago
ClinicalTrials.gov Identifier:
NCT00392561
First received: October 24, 2006
Last updated: December 18, 2012
Last verified: December 2012
History of Changes
  Purpose

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


Condition Intervention
Non-melanoma Skin Cancer
 Dietary Supplement: Selenium
Dietary Supplement: vitamin E

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Bangladesh Vitamin E and Selenium Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Skin Cancer [ Time Frame: Incidence during the 6-year study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: Occurrence during the 6-year study period ] [ Designated as safety issue: No ]
  • Diabetes [ Time Frame: Incidence within 6-year study period ] [ Designated as safety issue: No ]

Enrollment: 7000
Study Start Date: April 2006
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Selenium
 Dietary Supplement: Selenium
200 ug Selenium daily
Experimental: 2
Vitamin E
 Dietary Supplement: vitamin E
100 mg Vitamin E daily
Experimental: 3
Vitamin E + Selenium
 Dietary Supplement: Selenium
200 ug Selenium daily
Dietary Supplement: vitamin E
100 mg Vitamin E daily
No Intervention: Arm 4

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00392561

Locations
Bangladesh
Columbia University Arsenic Research Project
Dhaka, Bangladesh
ICDDR,B
Dhaka, Bangladesh
Sponsors and Collaborators
University of Chicago
Columbia University
Dartmouth-Hitchcock Medical Center
International Centre for Diarrhoeal Disease Research, Bangladesh
Investigators
Principal Investigator: Habibul Ahsan, MD University of Chicago
  More Information

No publications provided

Responsible Party: Habibul Ahsan, Professor, University of Chicago
ClinicalTrials.gov Identifier: NCT00392561     History of Changes
Other Study ID Numbers: 15091A (R01-CA10743-1), AAAB2309
Study First Received: October 24, 2006
Last Updated: December 18, 2012
Health Authority: Bangladesh: Ethical Review Committee

Additional relevant MeSH terms:
Skin Neoplasms
Carcinoma, Basal Cell
Carcinoma, Basosquamous
Carcinoma, Squamous Cell
Neoplasms by Site
Neoplasms
Skin Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Basal Cell
Neoplasms, Squamous Cell
Selenium
 Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Vitamins
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on May 23, 2013