Influence of Selenium on Prostate Cancer Related Biomarkers

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

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2014-05-31

Brief Summary

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Penn State Milton S. Hershey Medical Center researchers are trying to compare the effects of two different forms of selenium (selenium yeast and selenomethionine) on blood selenium levels and biomarkers of oxidative stress as primary endpoints. One in six men are at risk of getting prostate cancer in their lifetime. Participants will be asked to take over-the-counter selenium yeast supplements and selenomethionine or a placebo for nine out of twelve months.

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Detailed Description

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We will conduct a double-blind, randomized, placebo-controlled clinical study of selenium supplementation in the form of L-selenomethionine (SM)(200 µg/day) and selenium-enriched yeast (SY) (200 µg/day and 285 µg/day) for 9 months; the 285 µg/day SY is selected to deliver an equivalent selenium as in 200 µg/day SM to healthy men. The variability of SM in SY that will be used here is less than 3% and it accounts for 70.5% of the SM content in SY. As primary endpoints, we will determine the effects of these two forms of selenium on plasma levels of selenium and its metabolites as well as biomarkers of oxidative stress at several time points. As a secondary endpoint, the effect of these two forms of selenium on plasma PSA levels will be examined.

Conditions

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Effect of Selenium on Oxidative Stress in Healthy Men

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Low dose selenized-yeast

200 µg/day of selenized-yeast (SY)

Group Type EXPERIMENTAL

low dose selenized-yeast

Intervention Type DIETARY_SUPPLEMENT

200 µg/day of SY

selenomethionine

The second group will receive 200 µg/day of selenomethionine (SM)

Group Type EXPERIMENTAL

selenomethionine

Intervention Type DIETARY_SUPPLEMENT

200 µg/day of selenomethionine (SM)

Placebo

no active medication.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

no active medication

High dose selenized-yeast

The fourth group will receive 285 µg/day of selenized-yeast (SY).

Group Type EXPERIMENTAL

high dose selenized-yeast

Intervention Type DIETARY_SUPPLEMENT

285 µg/day of SY

Interventions

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Placebo

no active medication

Intervention Type OTHER

selenomethionine

200 µg/day of selenomethionine (SM)

Intervention Type DIETARY_SUPPLEMENT

low dose selenized-yeast

200 µg/day of SY

Intervention Type DIETARY_SUPPLEMENT

high dose selenized-yeast

285 µg/day of SY

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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SM low dose selenium-enriched yeast SY high dose selenium-enriched yeast SY

Eligibility Criteria

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Inclusion Criteria

* No history or evidence of diabetes
* Male between the ages of 20-79
* PSA levels ≤ 4.0 ng/mL
* Not taking \>50 µg/day selenium as a dietary supplement including multi- vitamins
* Non-smoker
* No concurrently participating or have participated in any other clinical trial within at least 30 days of registration
* Health male