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Influence of Selenium on Prostate Cancer Related Biomarkers

Primary Purpose

Effect of Selenium on Oxidative Stress in Healthy Men

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placebo
selenomethionine
low dose selenized-yeast
high dose selenized-yeast
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Effect of Selenium on Oxidative Stress in Healthy Men focused on measuring selenium, oxidative stress, prostate cancer, PSA, glucose

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Penn State Milton Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Arm Label

Low dose selenized-yeast

selenomethionine

Placebo

High dose selenized-yeast

Arm Description

200 µg/day of selenized-yeast (SY)

The second group will receive 200 µg/day of selenomethionine (SM)

no active medication.

The fourth group will receive 285 µg/day of selenized-yeast (SY).

Outcomes

Primary Outcome Measures

Biomarkers of oxidative stress

Secondary Outcome Measures

Plasma levels of selenium and selenium metabolites
PSA
Plasma Glucose

Full Information

First Posted
April 23, 2010
Last Updated
July 8, 2015
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01112449
Brief Title
Influence of Selenium on Prostate Cancer Related Biomarkers
Official Title
Influence of Selenium on Prostate Cancer Related Biomarkers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effect of Selenium on Oxidative Stress in Healthy Men
Keywords
selenium, oxidative stress, prostate cancer, PSA, glucose

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low dose selenized-yeast
Arm Type
Experimental
Arm Description
200 µg/day of selenized-yeast (SY)
Arm Title
selenomethionine
Arm Type
Experimental
Arm Description
The second group will receive 200 µg/day of selenomethionine (SM)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
no active medication.
Arm Title
High dose selenized-yeast
Arm Type
Experimental
Arm Description
The fourth group will receive 285 µg/day of selenized-yeast (SY).
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
no active medication
Intervention Type
Dietary Supplement
Intervention Name(s)
selenomethionine
Other Intervention Name(s)
SM
Intervention Description
200 µg/day of selenomethionine (SM)
Intervention Type
Dietary Supplement
Intervention Name(s)
low dose selenized-yeast
Other Intervention Name(s)
low dose selenium-enriched yeast, SY
Intervention Description
200 µg/day of SY
Intervention Type
Dietary Supplement
Intervention Name(s)
high dose selenized-yeast
Other Intervention Name(s)
high dose selenium-enriched yeast, SY
Intervention Description
285 µg/day of SY
Primary Outcome Measure Information:
Title
Biomarkers of oxidative stress
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Plasma levels of selenium and selenium metabolites
Time Frame
12 months
Title
PSA
Time Frame
12 months
Title
Plasma Glucose
Time Frame
12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karam El-Bayoumy, PhD
Organizational Affiliation
Penn State College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Milton Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24938534
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.
Results Reference
derived

Learn more about this trial

Influence of Selenium on Prostate Cancer Related Biomarkers

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