Selenium in the Prevention of Cancer

Cancer Clinical Trial

— DK PRECISE  

Official title:

Prevention of Cancer by Intervention With Selenium - A Pilot Study in a Danish Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01819649
• Other study ID #: OUH-DK-PILOT-PRECISE
• Status: Completed
• Phase: N/A
• First received: January 23, 2013
• Last updated: September 13, 2017
• Start date: November 1998
• Est. completion date: June 2004

Study information

• Verified date: September 2017
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a pilot study proceeding an intended international trial.

Hypothesis: Daily intake of selenium supplementation in the form of selenium-enriched yeast tablets will reduce the risk of cancer in healthy individuals.

Objective: The objective of this pilot study was to assess the viability of a full scale randomised trial.

AMENDMENT TO STUDY OBJECTIVE: Mortality analysis during intervention and follow-up as specified in the sections concerning study design and outcome measures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 491
• Est. completion date: June 2004
• Est. primary completion date: June 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 74 Years

Eligibility

Inclusion Criteria:

• WHO performance status 0 or 1

• No active liver- or kidney disease (Serum ALAT (alanine aminotransferase), alkalic phosphatase, bilirubin, creatinin or urea within 2 S.D of laboratory reference range)

• No previous cancer diagnosis

• No known HIV-infection

• Participant must understand oral and written information

• Participant must not use selenium supplementation of above 50 mcg/d

• Participant must give written consent prior to inclusion

Related Conditions & MeSH terms

• Cancer

Intervention

Dietary Supplement:
• SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/S

Locations

Country	Name	City	State
Denmark	Selenium Centre, Odense University Hospital	Odense C

Sponsors (13)

Lead Sponsor

Collaborator

Odense University Hospital

Cypress Systems, USA, Danish Cancer Society, Pharma Nord, The County of Funen, Denmark, The Dagmar Marshall Foundation, The Danish Directory of Food and Agriculture, The Foundation of Clinical Experimental Cancer Research, Odense, The Foundation of Lily Benthine Lund, The K.A. Rohde and Wife Foundation, The Memory Foundation of Merchant Brogaard, The N. O. Andersen Foundation, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viability of full scale study	At five years intervention (last participant last visit was june 2004) viability of full scale study was assessed according to the drop out rate, cost etc. of this pilot study.	At five years intervention
Secondary	AMENDMENT TO OUTCOME MEASURES: Mortality analysis.	Study participants will be followed up for mortality from the date of randomization in 1998-1999 through March 31, 2015. Vital status and date of death will be obtained from the Danish Civil Registration System. Information on the underlying cause of death will be obtained from the Danish Registry of Causes of Death through December 31, 2010 and from participant medical charts from January 1, 2011. Cause of death will be classified according to the 10th Revision of the International Classification of Diseases as death due to cancer (codes C00-C97), CVD (I00-I99), and all other causes.	Up to 17 years