Influence of Selenium on Prostate Cancer Related Biomarkers

July 8, 2015 updated by: Karam El-Bayoumy, Milton S. Hershey Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Milton Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low dose selenized-yeast
200 µg/day of selenized-yeast (SY)
Dietary supplement: low dose selenized-yeast
200 µg/day of SY
Other Names:
  • low dose selenium-enriched yeast
  • SY
Experimental: selenomethionine
The second group will receive 200 µg/day of selenomethionine (SM)
Dietary supplement: selenomethionine
200 µg/day of selenomethionine (SM)
Other Names:
  • SM
Placebo Comparator: Placebo
no active medication.
Other: Placebo
no active medication
Experimental: High dose selenized-yeast
The fourth group will receive 285 µg/day of selenized-yeast (SY).
Dietary supplement: high dose selenized-yeast
285 µg/day of SY
Other Names:
  • SY
  • high dose selenium-enriched yeast

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Biomarkers of oxidative stress
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma levels of selenium and selenium metabolites
Time Frame: 12 months
12 months
PSA
Time Frame: 12 months
12 months
Plasma Glucose
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

  • Principal Investigator: Karam El-Bayoumy, PhD, Penn State College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

April 23, 2010

First Submitted That Met QC Criteria

April 26, 2010

First Posted (Estimate)

April 28, 2010

Study Record Updates

Last Update Posted (Estimate)

July 10, 2015

Last Update Submitted That Met QC Criteria

July 8, 2015

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSHCI 08-012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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