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The Influence of Selenium on Biomarkers of Prostate Cancer Risk


N/A
20 Years
79 Years
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

The Influence of Selenium on Biomarkers of Prostate Cancer Risk


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 12 months; the 285 µg/day SY is selected to
deliver an equivalent selenium as in 200 µg/day SM to healthy men. Some time during the 12
months study period, all groups will take the placebo pill for at least 3 months. The
subjects will compose of African Americans, Hispanics, and white Americans in different age
groups defined as follows: Young adult (20-39 year old), Matured adult (40-59 year old), Old
adult (60-79 year old). The Young adult group will serve as a reference group and will be
used to validate our previous results. 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Outcome Measure:

PSA levels

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

Karam El-Bayoumy, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Penn State College of Medicine

Authority:

United States: Institutional Review Board

Study ID:

PSHCI 08-012

NCT ID:

NCT01112449

Start Date:

May 2008

Completion Date:

May 2013

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • PSA
  • testosterone
  • Prostatic Neoplasms

Name

Location

Penn State Milton Hershey Medical CenterHershey, Pennsylvania  17033