Selenium in the Prevention of Cancer

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

Sponsors

Lead Sponsor: Odense University Hospital

Collaborator: 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

Source 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.

Overall Status Completed
Start Date November 1998
Completion Date June 2004
Primary Completion Date June 2004
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Viability of full scale study At five years intervention
Secondary Outcome
Measure Time Frame
AMENDMENT TO OUTCOME MEASURES: Mortality analysis. Up to 17 years
Enrollment 491
Condition
Intervention

Intervention Type: Dietary Supplement

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

Eligibility

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

Gender: All

Minimum Age: 60 Years

Maximum Age: 74 Years

Healthy Volunteers: Accepts Healthy Volunteers

Location
Facility: Selenium Centre, Odense University Hospital
Location Countries

Denmark

Verification Date

September 2017

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Odense University Hospital

Investigator Full Name: Søren Cold

Investigator Title: M.D. PhD

Keywords
Has Expanded Access No
Number Of Arms 4
Arm Group

Label: Selenium enriched-yeast tablet; SelenoPRECISE 100 mcg/d

Type: Experimental

Label: Selenium enriched-yeast tablet; SelenoPRECISE 200 mcg/d

Type: Experimental

Label: Selenium enriched-yeast tablet; SelenoPRECISE 300 mcg/d

Type: Experimental

Label: Yeast tablet

Type: Placebo Comparator

Acronym DK PRECISE
Study Design Info

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.

Primary Purpose: Prevention

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov