Selenium in the Prevention of Cancer (DK PRECISE)
September 13, 2017 updated by: Søren Cold, Odense University Hospital
Prevention of Cancer by Intervention With Selenium - A Pilot Study in a Danish Population
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
491
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Odense C, Denmark, 5000
- Selenium Centre, Odense University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 74 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Selenium enriched-yeast tablet; SelenoPRECISE 100 mcg/d
|
|
|
Experimental: Selenium enriched-yeast tablet; SelenoPRECISE 200 mcg/d
|
|
|
Experimental: Selenium enriched-yeast tablet; SelenoPRECISE 300 mcg/d
|
|
|
Placebo Comparator: Yeast tablet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Viability of full scale study
Time Frame: At five years intervention
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
AMENDMENT TO OUTCOME MEASURES: Mortality analysis.
Time Frame: Up to 17 years
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 1998
Primary Completion (Actual)
June 1, 2004
Study Completion (Actual)
June 1, 2004
Study Registration Dates
First Submitted
January 23, 2013
First Submitted That Met QC Criteria
March 26, 2013
First Posted (Estimate)
March 27, 2013
Study Record Updates
Last Update Posted (Actual)
September 14, 2017
Last Update Submitted That Met QC Criteria
September 13, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OUH-DK-PILOT-PRECISE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.