ClinicalTrials.gov
ClinicalTrials.gov Menu

Bangladesh Vitamin E and Selenium Trial (BEST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00392561
Recruitment Status : Active, not recruiting
First Posted : October 26, 2006
Last Update Posted : September 6, 2017
Sponsor:
Collaborators:
Columbia University
Dartmouth-Hitchcock Medical Center
International Centre for Diarrhoeal Disease Research, Bangladesh
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Non-melanoma Skin Cancer Dietary Supplement: Selenium Dietary Supplement: vitamin E Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7000 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Bangladesh Vitamin E and Selenium Trial
Study Start Date : April 2006
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Skin Cancer [ Time Frame: Incidence during the 6-year study period ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: Occurrence during the 6-year study period ]
  2. Diabetes [ Time Frame: Incidence within 6-year study period ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00392561     History of Changes
Other Study ID Numbers: 15091A (R01-CA10743-1)
AAAB2309 ( Other Identifier: CUMC IRB )
First Posted: October 26, 2006    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases
Vitamins
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Selenium
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Trace Elements