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Influence of Selenium on Prostate Cancer Related Biomarkers

This study has been completed.
Information provided by (Responsible Party):
Karam El-Bayoumy, Milton S. Hershey Medical Center Identifier:
First received: April 23, 2010
Last updated: July 8, 2015
Last verified: October 2014
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.

Condition Intervention
Effect of Selenium on Oxidative Stress in Healthy Men
Other: Placebo
Dietary Supplement: selenomethionine
Dietary Supplement: low dose selenized-yeast
Dietary Supplement: high dose selenized-yeast

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Influence of Selenium on Prostate Cancer Related Biomarkers

Resource links provided by NLM:

Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Biomarkers of oxidative stress [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Plasma levels of selenium and selenium metabolites [ Time Frame: 12 months ]
  • PSA [ Time Frame: 12 months ]
  • Plasma Glucose [ Time Frame: 12 months ]

Enrollment: 130
Study Start Date: May 2008
Study Completion Date: May 2014
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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:
  • high dose selenium-enriched yeast
  • SY

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.

Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT01112449

United States, Pennsylvania
Penn State Milton Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Principal Investigator: Karam El-Bayoumy, PhD Penn State College of Medicine
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Karam El-Bayoumy, Professor of Biochemical and Molecular Biology, Milton S. Hershey Medical Center Identifier: NCT01112449     History of Changes
Other Study ID Numbers: PSHCI 08-012
Study First Received: April 23, 2010
Last Updated: July 8, 2015

Keywords provided by Milton S. Hershey Medical Center:
oxidative stress
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Trace Elements
Growth Substances processed this record on April 26, 2017