Non-melanoma Skin CancerBESTNCT00392561
Bangladesh Vitamin E and Selenium Trial
A study testing Selenium and vitamin E in people with Non-melanoma Skin Cancer, run by University of Chicago at 2 sites in Bangladesh.
Trial summary
The purpose of this study is to evaluate whether selenium and/or vitamin E are effective in preventing non-melanoma skin cancers. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Non-melanoma Skin Cancer
- What is being tested?
- Selenium and vitamin E
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,000 participants
- Where
- 2 sitesBangladesh
- Study dates
- 1 Apr 2006to 19 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Manifest arsenic skin lesions (melanosis, leucomelanosis, or keratosis)
- Aged 25 to 65 years
- Permanent resident of study area
Who cannot join
- Pregnancy
- Clinically too ill (enlarged spleen or liver)
- Presence of gangrene
- Cancer
Trial locations and contacts
2 sites in 1 country.
Bangladesh2 sites
Columbia University Arsenic Research Project
Dhaka
ICDDR,B
Dhaka
About this study
The purpose of this study is to evaluate whether selenium and/or vitamin E are effective in preventing non-melanoma skin cancers.
- Conditions
- Non-melanoma Skin Cancer
- Being tested
- Selenium, vitamin E
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeleniumDietary supplement
200 ug Selenium daily
vitamin EDietary supplement
100 mg Vitamin E daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Selenium Receives: Dietary Supplement: Selenium |
| 2 | Experimental | Vitamin E Receives: Dietary Supplement: vitamin E |
| 3 | Experimental | Vitamin E + Selenium Receives: Dietary Supplement: Selenium; Dietary Supplement: vitamin E |
| Arm 4 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Cancer
Measured: Incidence during the 6-year study period
Secondary outcomes (2)
Mortality
Measured: Occurrence during the 6-year study period
Diabetes
Measured: Incidence within 6-year study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2006 (estimated)
- Study start1 Apr 2006
- Primary completion19 Aug 2021
- Study completion19 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-melanoma Skin CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 7,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, Dartmouth-Hitchcock Medical Center, International Centre for Diarrhoeal Disease Research, Bangladesh
- Responsible party
- Sponsor
- Investigators
- Habibul Ahsan, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00392561
- Sponsor's protocol ID
- 15091A (R01-CA10743-1)
- Other IDs
- AAAB2309
- Acronym
- BEST
- Status last verified
- Apr 2023
- First submitted
- 24 Oct 2006
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jasmine F, Almazan A, Khamkevych Y, Argos M, Shahriar M, Islam T, Shea CR, Ahsan H, Kibriya MG. Gene-Environment Interaction: Small Deletions (DELs) and Transcriptomic Profiles in Non-Melanoma Skin Cancer (NMSC) and Potential Implications for Therapy. Cells. 2025 Jan 10;14(2):95. doi: 10.3390/cells14020095.
PubMed 39851523
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bangladesh Vitamin E and Selenium Trial
- ClinicalTrials.gov ID
- NCT00392561
- Acronym / sponsor ID
- BEST / 15091A (R01-CA10743-1)
- Conditions
- Non-melanoma Skin Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,000 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Columbia University, Dartmouth-Hitchcock Medical Center, International Centre for Diarrhoeal Disease Research, Bangladesh
- Study start
- 1 Apr 2006 (actual)
- Primary completion
- 19 Aug 2021 (actual)
- Study completion
- 19 Aug 2021 (actual)
- First posted
- 26 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether selenium and/or vitamin E are effective in preventing non-melanoma skin cancers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: SeleniumSelenium |
| 2 | Experimental | Dietary Supplement: vitamin EVitamin E |
| 3 | Experimental | Dietary Supplement: Selenium, Dietary Supplement: vitamin EVitamin E + Selenium |
| Arm 4 | No intervention | – |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Manifest arsenic skin lesions (melanosis, leucomelanosis, or keratosis)
- Aged 25 to 65 years
- Permanent resident of study area
Key exclusion criteria (4 listed)
- Pregnancy
- Clinically too ill (enlarged spleen or liver)
- Presence of gangrene
- Cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selenium200 ug Selenium daily | Dietary supplement | 1, 3 |
| vitamin E100 mg Vitamin E daily | Dietary supplement | 2, 3 |
Primary outcome
Skin Cancer
Time frame: Incidence during the 6-year study period
2 secondary outcomes
Mortality
Time frame: Occurrence during the 6-year study period
Diabetes
Time frame: Incidence within 6-year study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Derived from this study: PubMed 39851523Jasmine F, Almazan A, Khamkevych Y, Argos M, Shahriar M, Islam T, Shea CR, Ahsan H, Kibriya MG. Gene-Environment Interaction: Small Deletions (DELs) and Transcriptomic Profiles in Non-Melanoma Skin Cancer (NMSC) and Potential Implications for Therapy. Cells. 2025 Jan 10;14(2):95. doi: 10.3390/cells14020095.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Habibul Ahsan, MD principal investigator
University of Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selenium and vitamin E in people with Non-melanoma Skin Cancer, run by University of Chicago at 2 sites in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin Cancer (time frame: Incidence during the 6-year study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00392561, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.