NCT00392561

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2006

Completed
14.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2021

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

15.4 years

First QC Date

October 24, 2006

Last Update Submit

April 24, 2023

Conditions

Non-melanoma Skin Cancer

Outcome Measures

Primary Outcomes (1)

  • Skin Cancer

    Incidence during the 6-year study period

Secondary Outcomes (2)

  • Mortality

    Occurrence during the 6-year study period

  • Diabetes

    Incidence within 6-year study period

Study Arms (4)

1

EXPERIMENTAL

Selenium

Dietary Supplement: Selenium

2

EXPERIMENTAL

Vitamin E

Dietary Supplement: vitamin E

3

EXPERIMENTAL

Vitamin E + Selenium

Dietary Supplement: SeleniumDietary Supplement: vitamin E

Arm 4

NO INTERVENTION

Interventions

SeleniumDIETARY_SUPPLEMENT

200 ug Selenium daily

13
vitamin EDIETARY_SUPPLEMENT

100 mg Vitamin E daily

23

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Manifest arsenic skin lesions (melanosis, leucomelanosis, or keratosis)
  • Aged 25 to 65 years
  • Permanent resident of study area

You may not qualify if:

  • Pregnancy
  • Clinically too ill (enlarged spleen or liver)
  • Presence of gangrene
  • Cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Columbia University Arsenic Research Project

Dhaka, Bangladesh

Location

ICDDR,B

Dhaka, Bangladesh

Location

Related Publications (1)

  • 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.

    PMID: 39851523DERIVED

MeSH Terms

Interventions

SeleniumVitamin E

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsMineralsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Habibul Ahsan, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2006

First Posted

October 26, 2006

Study Start

April 1, 2006

Primary Completion

August 19, 2021

Study Completion

August 19, 2021

Last Updated

April 26, 2023

Record last verified: 2023-04

Locations

BA(2)