Influence of Selenium on Prostate Cancer Related Biomarkers

Not Applicable

Completed

• Conditions: Effect of Selenium on Oxidative Stress in Healthy Men
• Interventions: Other: Placebo; Dietary Supplement: low dose selenized-yeast; Dietary Supplement: high dose selenized-yeast; Dietary Supplement: selenomethionine

• Registration Number: NCT01112449
• Lead Sponsor: Milton S. Hershey Medical Center

Brief 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.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2010-04-23
• Study First Submitted QC: 2010-04-26
• Study First Posted: 2010-04-28
• Primary Completion: 2012-07
• Study Completion: 2014-05
• Status Verified: 2014-10
• Last Update Submitted: 2015-07-08
• Last Update Posted: 2015-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 130

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

Exclusion Criteria

• Evidence of prostate cancer
• Evidence of liver or kidney disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	no active medication.
Low dose selenized-yeast	low dose selenized-yeast	200 µg/day of selenized-yeast (SY)
High dose selenized-yeast	high dose selenized-yeast	The fourth group will receive 285 µg/day of selenized-yeast (SY).
selenomethionine	selenomethionine	The second group will receive 200 µg/day of selenomethionine (SM)

Primary Outcome Measures

Name	Time	Method
Biomarkers of oxidative stress	12 months

Secondary Outcome Measures

Name	Time	Method
Plasma levels of selenium and selenium metabolites	12 months
PSA	12 months
Plasma Glucose	12 months

Trial Locations

Locations (1)

Penn State Milton Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States