NCT01112449

Influence of Selenium on Prostate Cancer Related Biomarkers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: Male
• Age: 20 Years – 79 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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

• Effect of Selenium on Oxidative Stress in Healthy Men

Interventions

Type	Name	Description
OTHER	Placebo	no active medication
DIETARY_SUPPLEMENT	selenomethionine	200 µg/day of selenomethionine (SM)
DIETARY_SUPPLEMENT	low dose selenized-yeast	200 µg/day of SY
DIETARY_SUPPLEMENT	high dose selenized-yeast	285 µg/day of SY

Timeline

• Start date: 2008-05-01
• Primary completion: 2012-07-01
• Completion: 2014-05-01
• First posted: 2010-04-28
• Last updated: 2015-07-10

Locations

1 site across 1 country: United States