Influence of Selenium on Prostate Cancer Related Biomarkers

Penn State Health

Status: Completed

Conditions: Effect of Selenium on Oxidative Stress in Healthy Men

Treatments: Dietary Supplement: high dose selenized-yeast; Other: Placebo; Dietary Supplement: low dose selenized-yeast; Dietary Supplement: selenomethionine

Study type: Interventional

Funder types: Other

Identifiers

NCT01112449

PSHCI 08-012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 patients

Sex: Male

Ages: 20 to 79 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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130 participants in 4 patient groups, including a placebo group

Low dose selenized-yeast

Experimental group

Description:

200 µg/day of selenized-yeast (SY)

Treatment:

Dietary Supplement: low dose selenized-yeast

selenomethionine

Experimental group

Description:

The second group will receive 200 µg/day of selenomethionine (SM)

Treatment:

Dietary Supplement: selenomethionine

Placebo

Placebo Comparator group

Description:

no active medication.

Treatment:

Other: Placebo

High dose selenized-yeast

Experimental group

Description:

The fourth group will receive 285 µg/day of selenized-yeast (SY).

Treatment:

Dietary Supplement: high dose selenized-yeast