Bangladesh Vitamin E and Selenium Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 8 May 2023
• Main ID: NCT00392561
• Date of registration: 24/10/2006
• Prospective Registration: No
• Primary sponsor: University of Chicago
• Public title: Bangladesh Vitamin E and Selenium Trial BEST
• Scientific title: Bangladesh Vitamin E and Selenium Trial
• Date of first enrolment: April 1, 2006
• Target sample size: 7000
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00392561
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: N/A

Countries of recruitment

Bangladesh

Contacts

• Name: Habibul Ahsan, MD
• Affiliation: University of Chicago

Key inclusion & exclusion 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



Age minimum: 25 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Non-melanoma Skin Cancer

Intervention(s)

Dietary Supplement: Selenium

Dietary Supplement: vitamin E

Primary Outcome(s)

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

Secondary Outcome(s)

Diabetes [Time Frame: Incidence within 6-year study period]

Mortality [Time Frame: Occurrence during the 6-year study period]

Secondary ID(s)

AAAB2309

15091A (R01-CA10743-1)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Columbia University

Dartmouth-Hitchcock Medical Center

International Centre for Diarrhoeal Disease Research, Bangladesh