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UK PREvention of Cancer by Intervention with SElenium
ISRCTN ISRCTN25193534
DOI 10.1186/ISRCTN25193534
ClinicalTrials.gov identifier NCT00022165
EudraCT number
Public title UK PREvention of Cancer by Intervention with SElenium
Scientific title UK PREvention of Cancer by Intervention with SElenium: a pilot randomised controlled feasibility study
Acronym UK PRECISE Pilot Study
Serial number at source N/A
Study hypothesis The PRECISE trial aims to show not only whether selenium has a protective effect against cancer, but also how much selenium is needed to have this effect and which people will benefit most.

Added as of 27/03/2009: Please note that the main trial never started due to lack of funding. The pilot study was successfully completed, and the pilot trial information was added to this record on 12/07/2010. All changes can be found below in the relevant section with the above update date.
Lay summary Not provided at time of registration
Ethics approval Added 13/07/2010:
1. South Tees Research Ethics Committee approved on the 1st February 2000 (ref: 99/69)
2. Worcestershire Health Authority Local Research Ethics Committee approved on the 17th March 2000 (ref: LREC 74/99)
3. Norwich District Research Ethics Committee approved on the 9th December 1999 (ref: LREC 99/141)
4. Great Yarmouth and Waveney LREC approved on the 22nd February 2000 (under reciprocal arrangements with Norwich District LREC)
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Multiple cancer sites
Participants - inclusion criteria Volunteers aged 60 - 74 years old, either sex
Participants - exclusion criteria Added 12/07/2010:
1. Southwest Oncology Group (SWOG) grading scale performance status score greater than 1 or equivalent
2. Active liver or kidney disease (known abnormal liver or kidney function)
3. Prior diagnosis of cancer (excluding non-melanoma skin cancer)
4. Diagnosed human immunodeficiency virus (HIV) infection
5. Diminished mental capacity (subjects must be able to give informed consent to participate as defined by ethics committees)
6. Taking 50 µg/day or more of selenium supplements
Anticipated start date 01/01/2000
Anticipated end date 31/12/2002
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 14500 in total (500 for pilot arm - added 12/07/2010)
Interventions Current information as of 12/07/2010:
Participants receive either a 100 µg, 200 µg, 300 µg selenium as selenium-enriched yeast supplement or a placebo yeast supplement every day for six months. Follow-up was for a minimum of six months (we had hoped this pilot would lead into the main trial phase).

Previous information at time of registration:
Participants receive either a 100 µg, 200 µg, 300 µg selenium supplement or a placebo every day.
Primary outcome measure(s) Added 12/07/2010:
This was a feasibility study to show the ability to run the main trial.
Secondary outcome measure(s) Added 12/07/2010:
1. Mood (Profile of Mood States Bi-Polar Form [POMS-BI]), measured at baseline and 6 months
2. Quality of life (36-item Short Form Health Survey [SF-36]), measured at baseline and 6 months
3. Thyroid function (thyroid stimulating hormone [TSH], total and free T4 and T3), measured at baseline and six months
Sources of funding Cancer Research Campaign (UK) - funded a pilot trial for this study, completed in 2002
Trial website
Publications 1. 2006 selenium supplementation, mood and quality of life results in http://www.ncbi.nlm.nih.gov/pubmed/16181615
2. 2008 selenium supplementation and thyroid function results in http://www.ncbi.nlm.nih.gov/pubmed/18258627
3. 2008 supplementation with selenium does not affect total homocysteine concentration in the UK elderly population: http://www.ncbi.nlm.nih.gov/pubmed/18683819
4. 2011 high-selenium yeast on plasma lipids results in http://www.ncbi.nlm.nih.gov/pubmed/21576533
Contact name Prof  Margaret  Rayman
  Address Faculty of Health and Medical Sciences
University of Surrey
  City/town Guildford
  Zip/Postcode GU2 5XH
  Country United Kingdom
  Tel +44 (0)1483 686447
  Fax +44 (0)1483 686401
  Email M.Rayman@surrey.ac.uk
Sponsor Cancer Research UK (CRUK) (UK)
  Address PO Box 123
61 Lincoln's Inn Fields
  City/town London
  Zip/Postcode WC2A 3PX
  Country United Kingdom
  Sponsor website: http://www.cancerresearchuk.org/
Date applied 18/05/2001
Last edited 02/02/2012
Date ISRCTN assigned 18/05/2001
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