Influence of Selenium on Prostate Cancer Related Biomarkers
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 20 - 79 |
| Updated: | 4/21/2016 |
| Start Date: | May 2008 |
| End Date: | May 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.
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.
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.
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.
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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