Selenium supplementation for the prevention of hepatocellular carcinomas in HBsAg positive patients (pilot study)

ISRCTN ISRCTN38534743
DOI https://doi.org/10.1186/ISRCTN38534743
Secondary identifying numbers N/A
Submission date
06/06/2003
Registration date
23/09/2003
Last edited
18/10/2012
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Kar Keung Cheng
Scientific

Department of Public Health & Epidemiology
The University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

Email K.K.Cheng@bham.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedPrevention of primary liver cancer with selenium supplementation - targeted to high risk population
InterventionEligible patients who consent to participate will be randomly allocated to the selenium group (oral selenium supplementation: 200mg selenium per day, in the form of selenized yeast tablet) or control group (receiving placebo).
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Selenium
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2000
Completion date01/01/2002
Reason abandoned (if study stopped)Lack of funding

Eligibility

Participant type(s)Patient
Age groupAdult
SexMale
Target number of participantsNot provided at time of registration
Key inclusion criteriaParticipants will include:
1. Men aged 45 to 64 with positive HBsAg (hepatitis B surface antigen) test
2. Negative AFP (alphafetoprotein) test
3. Normal ALT (alanine aminotransferase) values
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/2000
Date of final enrolment01/01/2002

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Public Health & Epidemiology
Birmingham
B15 2TT
United Kingdom

Sponsor information

The University of Birmingham (UK)
University/education

Department of Public Health & Epidemiology
Edgbaston
Birmingham
B15 2TT
England
United Kingdom

Email p.adab@bham.ac.uk
ROR logo "ROR" https://ror.org/03angcq70

Funders

Funder type

University/education

University of Birmingham (UK) - The Department of Public Health and Epidemiology is supporting the pilot phase of this study

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan