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

  • Denmark
      • 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
Dietary supplement: SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/S
Experimental: Selenium enriched-yeast tablet; SelenoPRECISE 200 mcg/d
Dietary supplement: SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/S
Experimental: Selenium enriched-yeast tablet; SelenoPRECISE 300 mcg/d
Dietary supplement: SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/S
Placebo Comparator: Yeast tablet
Dietary supplement: SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/S

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

Odense University Hospital

Collaborators

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

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.

General Publications

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

Keywords

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.

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