View Clinical Trial (Medical Research Study)
The Influence of Selenium on Biomarkers of Prostate Cancer Risk
| City: |
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Hershey |
| State: |
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Pennsylvania |
| Zip Code: |
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17033 |
| Conditions: |
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Prostate Cancer |
| Purpose: |
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Penn State Milton S. Hershey Medical Center researchers are trying to determine if selenium
yeast and selenomethionine lower prostate-specific antigen levels and prevent other markers
related to prostate cancer development in healthy individuals of different age groups. 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 twelve out of eighteen months.
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| Study Summary: |
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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.
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| Criteria: |
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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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| NCT ID: |
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NCT01112449 |
| Primary Contact: |
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Principal Investigator
Karam El-Bayoumy, PhD
Penn State College of Medicine
Karam El-Bayoumy, PhD
Phone: 717-531-1005
Email: kee2@psu.edu
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| Backup Contact: |
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Email: wneidig@hmc.psu.edu
Wanda Neidig
Phone: 717-531-1002
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| Location Contact: |
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Hershey, Pennsylvania 17033
United States
Karem El-Bayoumy, PhD
Phone: 717-531-1005
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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