Selenium supplementation for the prevention of hepatocellular carcinomas in HBsAg positive patients (pilot study)
| ISRCTN | ISRCTN38534743 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38534743 |
| Protocol serial number | N/A |
| Sponsor | The University of Birmingham (UK) |
| Funder | University of Birmingham (UK) - The Department of Public Health and Epidemiology is supporting the pilot phase of this study |
- 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
Scientific
Department of Public Health & Epidemiology
The University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
| K.K.Cheng@bham.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Prevention of primary liver cancer with selenium supplementation - targeted to high risk population |
| Intervention | Eligible 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 type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Selenium |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/01/2002 |
| Reason abandoned (if study stopped) | Lack of funding |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Key inclusion criteria | Participants 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 criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2000 |
| Date of final enrolment | 01/01/2002 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Public Health & Epidemiology
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
