Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 30 of 228 for:    yeast

Selenium in the Prevention of Cancer (DK PRECISE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01819649
Recruitment Status : Completed
First Posted : March 27, 2013
Last Update Posted : September 14, 2017
Sponsor:
Collaborators:
Danish Cancer Society
University of Southern Denmark
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
Pharma Nord
Information provided by (Responsible Party):
Søren Cold, Odense University Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Cancer Dietary Supplement: SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/S Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 491 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: AMENDMENT TO STUDY DESIGN: Towards the end of the intervention period, it was decided to follow-up participants for an additional ten years via Danish public registries for data on morbidity and mortality.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Prevention of Cancer by Intervention With Selenium - A Pilot Study in a Danish Population
Study Start Date : November 1998
Actual Primary Completion Date : June 2004
Actual Study Completion Date : June 2004

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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01819649


Locations
Layout table for location information
Denmark
Selenium Centre, Odense University Hospital
Odense C, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Danish Cancer Society
University of Southern Denmark
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
Pharma Nord

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Søren Cold, M.D. PhD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01819649     History of Changes
Other Study ID Numbers: OUH-DK-PILOT-PRECISE
First Posted: March 27, 2013    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017
Keywords provided by Søren Cold, Odense University Hospital:
selenium
selenium supplementation
randomised controlled trial
prevention
Additional relevant MeSH terms:
Layout table for MeSH terms
Selenium
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Nutrients
Growth Substances