Selenium in the Prevention of Cancer

N/ACompletedNCT01819649

Odense University Hospital491 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

491

Conditions

Cancer

Interventions

SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/SDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 60 YearsMax age: 74 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Selenium Centre, Odense University Hospital

Odense C, Denmark

Outcomes

Primary Outcomes

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.

Time frame: At five years intervention

Secondary Outcomes

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.

Time frame: Up to 17 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.