Influence of Selenium on Prostate Cancer Related Biomarkers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Karam El-Bayoumy, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01112449
First received: April 23, 2010
Last updated: May 16, 2014
Last verified: January 2014
  Purpose

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 Prostate Cancer Related Biomarkers in Healthy Men
Other: Placebo
Drug: SM
Drug: Third Group
Drug: Fourth Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, 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:
  • Plasma levels of selenium and selenium metabolites [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Biomarkers of oxidative stress [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PSA [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Plasma Glucose [ Time Frame: 12 ] [ Designated as safety issue: No ]

Enrollment: 130
Study Start Date: May 2008
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Third Group
The third group will receive 200 µg/day of SY
Drug: Third Group
The third group will receive 200 µg/day of SY
Other Names:
  • selenium-enriched yeast
  • SY
Experimental: Second Group
The second group will receive 200 µg/day of SM
Drug: SM
200 µg/day of selenomethionine (SM)
Other Names:
  • selenomethionine
  • SM
Placebo Comparator: Treatment Group One
One group will receive placebo, no active medication.
Other: Placebo
One group will receive placebo
Other Name: Placebo
Experimental: Fourth Goup

The fourth group will receive 285 µg/day of SY.

All subjects will take one pill daily for 12 months and report for outpatient visits at 3, 6, 9 and 12 months and have blood and urine samples collected.

Drug: Fourth Group
The fourth group will receive 285 µg/day of SY
Other Names:
  • 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.

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01112449

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

No publications provided by Milton S. Hershey Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karam El-Bayoumy, Professor of Biochemical and Molecular Biology, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01112449     History of Changes
Other Study ID Numbers: PSHCI 08-012
Study First Received: April 23, 2010
Last Updated: May 16, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Selenium
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on September 22, 2014