Influence of Selenium on Prostate Cancer Related Biomarkers

Effect of Selenium on Oxidative Stress in Healthy Men Clinical Trial

Official title:

Influence of Selenium on Prostate Cancer Related Biomarkers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01112449
• Other study ID #: PSHCI 08-012
• Status: Completed
• Phase: N/A
• First received: April 23, 2010
• Last updated: July 8, 2015
• Start date: May 2008
• Est. completion date: May 2014

Study information

• Verified date: October 2014
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: May 2014
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 79 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Effect of Selenium on Oxidative Stress in Healthy Men
• Prostatic Neoplasms

Intervention

Other:
• Placebo
no active medication

Dietary Supplement:
• selenomethionine
200 µg/day of selenomethionine (SM)
• low dose selenized-yeast
200 µg/day of SY
• high dose selenized-yeast
285 µg/day of SY

Locations

Country	Name	City	State
United States	Penn State Milton Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarkers of oxidative stress		12 months	No
Secondary	Plasma levels of selenium and selenium metabolites		12 months	No
Secondary	PSA		12 months	No
Secondary	Plasma Glucose		12 months	No