Selenium in the Prevention of Cancer

Study Overview
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Brief Summary
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Dietary Supplement: SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/S


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Selenium enriched-yeast tablet; SelenoPRECISE 100 mcg/d<br> | Dietary Supplement: SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/S<br> <br> |
| Experimental: Selenium enriched-yeast tablet; SelenoPRECISE 200 mcg/d<br> | Dietary Supplement: SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/S<br> <br> |
| Experimental: Selenium enriched-yeast tablet; SelenoPRECISE 300 mcg/d<br> | Dietary Supplement: SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/S<br> <br> |
| Placebo Comparator: Yeast tablet<br> | Dietary Supplement: SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/S<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viability of full scale study | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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selenium, selenium supplementation, randomised controlled trial, prevention