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Influence of Selenium on Prostate Cancer Related Biomarkers

Information source: Milton S. Hershey Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Effect of Selenium on Oxidative Stress in Healthy Men

Intervention: Placebo (Other); selenomethionine (Dietary Supplement); low dose selenized-yeast (Dietary Supplement); high dose selenized-yeast (Dietary Supplement)

Phase: N/A

Status: Completed

Sponsored by: Milton S. Hershey Medical Center

Official(s) and/or principal investigator(s):
Karam El-Bayoumy, PhD, Principal Investigator, Affiliation: Penn State College of Medicine

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.

Clinical Details

Official title: Influence of Selenium on Prostate Cancer Related Biomarkers

Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Primary outcome: Biomarkers of oxidative stress

Secondary outcome:

Plasma levels of selenium and selenium metabolites

PSA

Plasma Glucose

Detailed description: We will conduct a double-blind, randomized, placebo-controlled clinical study of selenium supplementation in the form of L-selenomethionine (SM)(200 g/day) and selenium-enriched yeast (SY) (200 g/day and 285 g/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

Minimum age: 20 Years. Maximum age: 79 Years. Gender(s): Male.

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

Locations and Contacts

Penn State Milton Hershey Medical Center, Hershey, Pennsylvania 17033, United States
Additional Information

Starting date: May 2008
Last updated: July 8, 2015

Page last updated: August 23, 2015

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