NCT01112449

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 28, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

July 10, 2015

Status Verified

October 1, 2014

Enrollment Period

4.2 years

First QC Date

April 23, 2010

Last Update Submit

July 8, 2015

Conditions

Effect of Selenium on Oxidative Stress in Healthy Men

Keywords

seleniumoxidative stressprostate cancerPSAglucose

Outcome Measures

Primary Outcomes (1)

  • Biomarkers of oxidative stress

    12 months

Secondary Outcomes (3)

  • Plasma levels of selenium and selenium metabolites

    12 months

  • PSA

    12 months

  • Plasma Glucose

    12 months

Study Arms (4)

Low dose selenized-yeast

EXPERIMENTAL

200 µg/day of selenized-yeast (SY)

Dietary Supplement: low dose selenized-yeast

selenomethionine

EXPERIMENTAL

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

Dietary Supplement: selenomethionine

Placebo

PLACEBO COMPARATOR

no active medication.

Other: Placebo

High dose selenized-yeast

EXPERIMENTAL

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

Dietary Supplement: high dose selenized-yeast

Interventions

PlaceboOTHER

no active medication

Placebo
selenomethionineDIETARY_SUPPLEMENT

200 µg/day of selenomethionine (SM)

Also known as: SM
selenomethionine
low dose selenized-yeastDIETARY_SUPPLEMENT

200 µg/day of SY

Also known as: low dose selenium-enriched yeast, SY
Low dose selenized-yeast
high dose selenized-yeastDIETARY_SUPPLEMENT

285 µg/day of SY

Also known as: high dose selenium-enriched yeast, SY
High dose selenized-yeast

Eligibility Criteria

Age20 Years - 79 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Milton Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (1)

  • 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.

    PMID: 24938534DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Selenomethionine

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Organoselenium CompoundsOrganic ChemicalsMethionineAmino Acids, SulfurSulfur CompoundsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Karam El-Bayoumy, PhD

    Penn State College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Biochemical and Molecular Biology

Study Record Dates

First Submitted

April 23, 2010

First Posted

April 28, 2010

Study Start

May 1, 2008

Primary Completion

July 1, 2012

Study Completion

May 1, 2014

Last Updated

July 10, 2015

Record last verified: 2014-10

Locations

US(1)