Selenium in the Prevention of Cancer (DK PRECISE)

Odense University Hospital

Status: Completed

Conditions: Cancer

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01819649

OUH-DK-PILOT-PRECISE

Details and patient eligibility

About

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.

Enrollment: 491 patients

Sex: All

Ages: 60 to 74 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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491 participants in 4 patient groups, including a placebo group

Selenium enriched-yeast tablet; SelenoPRECISE 100 mcg/d

Experimental group

Treatment:

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

Selenium enriched-yeast tablet; SelenoPRECISE 200 mcg/d

Experimental group

Treatment:

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

Selenium enriched-yeast tablet; SelenoPRECISE 300 mcg/d

Experimental group

Treatment:

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

Yeast tablet

Placebo Comparator group

Treatment:

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