Clinical trial NCT01112449: Influence of Selenium on Prostate Cancer Related Biomarkers
Official title: Influence of Selenium on Prostate Cancer Related Biomarkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effect of Selenium on Oxidative Stress in Healthy Men
Keywords: selenium
oxidative stress
prostate cancer
PSA
glucose
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2010-04-28
Enrollment: 130
Sex: MALE
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Biomarkers of oxidative stress
timeFrame: 12 months
Secondary outcomes:
measure: Plasma levels of selenium and selenium metabolites
timeFrame: 12 months
measure: PSA
timeFrame: 12 months
measure: Plasma Glucose
timeFrame: 12 months
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine
name: Karam El-Bayoumy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Richie JP Jr, Das A, Calcagnotto AM, Sinha R, Neidig W, Liao J, Lengerich EJ, Berg A, Hartman TJ, Ciccarella A, Baker A, Kaag MG, Goodin S, DiPaola RS, El-Bayoumy K. Comparative effects of two different forms of selenium on oxidative stress biomarkers in healthy men: a randomized clinical trial. Cancer Prev Res (Phila). 2014 Aug;7(8):796-804. doi: 10.1158/1940-6207.CAPR-14-0042. Epub 2014 Jun 17.