Bangladesh Vitamin E and Selenium Trial

NCT ID: NCT00392561

Last Updated: 2023-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-01

Study Completion Date

2021-08-19

Brief Summary

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

Detailed Description

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Conditions

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Non-melanoma Skin Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Selenium

Group Type EXPERIMENTAL

Selenium

Intervention Type DIETARY_SUPPLEMENT

200 ug Selenium daily

2

Vitamin E

Group Type EXPERIMENTAL

vitamin E

Intervention Type DIETARY_SUPPLEMENT

100 mg Vitamin E daily

3

Vitamin E + Selenium

Group Type EXPERIMENTAL

Selenium

Intervention Type DIETARY_SUPPLEMENT

200 ug Selenium daily

vitamin E

Intervention Type DIETARY_SUPPLEMENT

100 mg Vitamin E daily

Arm 4

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Selenium

200 ug Selenium daily

Intervention Type DIETARY_SUPPLEMENT

vitamin E

100 mg Vitamin E daily

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Columbia University

OTHER

Sponsor Role collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role collaborator

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Habibul Ahsan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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Columbia University Arsenic Research Project

Dhaka, , Bangladesh

Site Status

ICDDR,B

Dhaka, , Bangladesh

Site Status

Countries

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Bangladesh

References

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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.

Reference Type DERIVED
PMID: 39851523 (View on PubMed)

Other Identifiers

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AAAB2309

Identifier Type: OTHER

Identifier Source: secondary_id

15091A (R01-CA10743-1)

Identifier Type: -

Identifier Source: org_study_id

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