Selenium in the Prevention of Cancer

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Dietary Supplement: SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/S

• Registration Number: NCT01819649
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-11
• Primary Completion: 2004-06
• Study Completion: 2004-06
• Study First Submitted: 2013-01-23
• Study First Submitted QC: 2013-03-26
• Study First Posted: 2013-03-27
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-13
• Last Update Posted: 2017-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 491

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Selenium enriched-yeast tablet; SelenoPRECISE 300 mcg/d	SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/S	-
Selenium enriched-yeast tablet; SelenoPRECISE 100 mcg/d	SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/S	-
Yeast tablet	SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/S	-
Selenium enriched-yeast tablet; SelenoPRECISE 200 mcg/d	SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/S	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Selenium Centre, Odense University Hospital; 🇩🇰 Odense C, Denmark