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Completed

NCT Number: NCT01819649

Selenium in the Prevention of Cancer

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.

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Key information

Conditions

Cancer Neoplasms

Age range

60 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Selenium Centre, Odense University Hospital

Odense C, 5000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/S

Dietary Supplement

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • Cypress Systems, USA
  • Danish Cancer Society
  • K. A. Rohde's and wife's Foundation
  • 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 Memory Foundation of Merchant Brogaard
  • The N. O. Andersen Foundation
  • University of Southern Denmark

Registry information

Official study title

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

Acronym: DK PRECISE

Important dates

Study start
1998
Primary completion
2004
Study completion
2004
First posted
Mar 27, 2013
Registry last updated
Sep 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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