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Completed

NCT Number: NCT01112449

Influence of Selenium on Prostate Cancer Related Biomarkers

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.

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Key information

Conditions

Effect of Selenium on Oxidative Stress in Healthy Men Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

20 year–79 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Penn State Milton Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Other

no active medication

selenomethionine

Dietary Supplement

200 µg/day of selenomethionine (SM)

Other names: SM

low dose selenized-yeast

Dietary Supplement

200 µg/day of SY

Other names: low dose selenium-enriched yeast, SY

high dose selenized-yeast

Dietary Supplement

285 µg/day of SY

Other names: high dose selenium-enriched yeast, SY

Primary outcomes

  1. Biomarkers of oxidative stress

    Time frame: 12 months

Secondary outcomes

  1. Plasma levels of selenium and selenium metabolites

    Time frame: 12 months

  2. PSA

    Time frame: 12 months

  3. Plasma Glucose

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2014
First posted
Apr 28, 2010
Registry last updated
Jul 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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