Selenium in the Prevention of Cancer

NCT ID: NCT01819649

Last Updated: 2017-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

491 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-11-30

Study Completion Date

2004-06-30

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.

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Selenium enriched-yeast tablet; SelenoPRECISE 100 mcg/d

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_SUPPLEMENT

Selenium enriched-yeast tablet; SelenoPRECISE 200 mcg/d

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_SUPPLEMENT

Selenium enriched-yeast tablet; SelenoPRECISE 300 mcg/d

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_SUPPLEMENT

Yeast tablet

Group Type PLACEBO_COMPARATOR

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

Intervention Type DIETARY_SUPPLEMENT

Interventions

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

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

60 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Danish Cancer Society

OTHER

Sponsor Role collaborator

University of Southern Denmark

OTHER

Sponsor Role collaborator

K. A. Rohde's and wife's Foundation

OTHER

Sponsor Role collaborator

The County of Funen, Denmark

OTHER_GOV

Sponsor Role collaborator

Cypress Systems, USA

UNKNOWN

Sponsor Role collaborator

The Dagmar Marshall Foundation

OTHER

Sponsor Role collaborator

The N. O. Andersen Foundation

UNKNOWN

Sponsor Role collaborator

The Danish Directory of Food and Agriculture

UNKNOWN

Sponsor Role collaborator

The Foundation of Clinical Experimental Cancer Research, Odense

UNKNOWN

Sponsor Role collaborator

The Foundation of Lily Benthine Lund

UNKNOWN

Sponsor Role collaborator

The Memory Foundation of Merchant Brogaard

UNKNOWN

Sponsor Role collaborator

Pharma Nord

INDUSTRY

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Søren Cold

M.D. PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Selenium Centre, Odense University Hospital

Odense C, , Denmark

Site Status

Countries

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Denmark

References

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Cold F, Winther KH, Pastor-Barriuso R, Rayman MP, Guallar E, Nybo M, Griffin BA, Stranges S, Cold S. Randomised controlled trial of the effect of long-term selenium supplementation on plasma cholesterol in an elderly Danish population. Br J Nutr. 2015 Dec 14;114(11):1807-18. doi: 10.1017/S0007114515003499. Epub 2015 Sep 30.

Reference Type DERIVED
PMID: 26420334 (View on PubMed)

Other Identifiers

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OUH-DK-PILOT-PRECISE

Identifier Type: -

Identifier Source: org_study_id

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