Cancer
Conditions
Keywords
selenium, selenium supplementation, randomised controlled trial, prevention
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.
Interventions
DIETARY_SUPPLEMENTSelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/S
Sponsors
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
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
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.
Eligibility
Sex/Gender
ALL
Age
60 Years to 74 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Viability of full scale study | 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
| Measure | Time frame | Description |
|---|---|---|
| AMENDMENT TO OUTCOME MEASURES: Mortality analysis. | 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. |
Countries
Denmark
Outcome results
None listed