Effect of Selenium on Oxidative Stress in Healthy MenNCT01112449
Influence of Selenium on Prostate Cancer Related Biomarkers
A study testing selenomethionine, low dose selenized-yeast and high dose selenized-yeast in people with Effect of Selenium on Oxidative Stress in Healthy Men, run by Milton S. Hershey Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 79 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Effect of Selenium on Oxidative Stress in Healthy Men
- What is being tested?
- selenomethionine, low dose selenized-yeast and high dose selenized-yeast
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Evidence of prostate cancer
- Evidence of liver or kidney disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
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.
Read the detailed 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.
- Being tested
- Placebo, selenomethionine, low dose selenized-yeast, high dose selenized-yeast
- Keywords
- selenium, oxidative stress, prostate cancer, PSA, glucose
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
no active medication
selenomethionineDietary supplement
Also called SM
200 µg/day of selenomethionine (SM)
low dose selenized-yeastDietary supplement
Also called low dose selenium-enriched yeast, SY
200 µg/day of SY
high dose selenized-yeastDietary supplement
Also called high dose selenium-enriched yeast, SY
285 µg/day of SY
| Study group | Role | What they receive |
|---|---|---|
| Low dose selenized-yeast | Experimental | 200 µg/day of selenized-yeast (SY) Receives: Dietary Supplement: low dose selenized-yeast |
| selenomethionine | Experimental | The second group will receive 200 µg/day of selenomethionine (SM) Receives: Dietary Supplement: selenomethionine |
| Placebo | Placebo comparator | no active medication. Receives: Other: Placebo |
| High dose selenized-yeast | Experimental | The fourth group will receive 285 µg/day of selenized-yeast (SY). Receives: Dietary Supplement: high dose selenized-yeast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers of oxidative stress
Measured: 12 months
Secondary outcomes (3)
Plasma levels of selenium and selenium metabolites
Measured: 12 months
PSA
Measured: 12 months
Plasma Glucose
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startMay 2008
- Primary completionJul 2012
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Effect of Selenium on Oxidative Stress in Healthy MenStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karam El-Bayoumy, Milton S. Hershey Medical Center
- Investigators
- Karam El-Bayoumy, PhD, Principal investigator, Penn State College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112449
- Sponsor's protocol ID
- PSHCI 08-012
- Status last verified
- Oct 2014
- First submitted
- 23 Apr 2010
- Last updated
- 10 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Richie JP Jr, Das A, Calcagnotto AM, Sinha R, Neidig W, Liao J, Lengerich EJ, Berg A, Hartman TJ, Ciccarella A, Baker A, Kaag MG, Goodin S, DiPaola RS, El-Bayoumy K. Comparative effects of two different forms of selenium on oxidative stress biomarkers in healthy men: a randomized clinical trial. Cancer Prev Res (Phila). 2014 Aug;7(8):796-804. doi: 10.1158/1940-6207.CAPR-14-0042. Epub 2014 Jun 17.
PubMed 24938534
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Selenium on Prostate Cancer Related Biomarkers
- ClinicalTrials.gov ID
- NCT01112449
- Acronym / sponsor ID
- PSHCI 08-012
- Keywords
- selenium, oxidative stress, prostate cancer, PSA, glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jul 2012 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 28 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose selenized-yeast | Experimental | Dietary Supplement: low dose selenized-yeast200 µg/day of selenized-yeast (SY) |
| selenomethionine | Experimental | Dietary Supplement: selenomethionineThe second group will receive 200 µg/day of selenomethionine (SM) |
| Placebo | Placebo comparator | Other: Placebono active medication. |
| High dose selenized-yeast | Experimental | Dietary Supplement: high dose selenized-yeastThe fourth group will receive 285 µg/day of selenized-yeast (SY). |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Evidence of prostate cancer
- Evidence of liver or kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebono active medication | Other | Placebo |
| selenomethionineAlso: SM200 µg/day of selenomethionine (SM) | Dietary supplement | selenomethionine |
| low dose selenized-yeastAlso: low dose selenium-enriched yeast, SY200 µg/day of SY | Dietary supplement | Low dose selenized-yeast |
| high dose selenized-yeastAlso: high dose selenium-enriched yeast, SY285 µg/day of SY | Dietary supplement | High dose selenized-yeast |
Primary outcome
Biomarkers of oxidative stress
Time frame: 12 months
3 secondary outcomes
Plasma levels of selenium and selenium metabolites
Time frame: 12 months
PSA
Time frame: 12 months
Plasma Glucose
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2015.
- Derived from this study: PubMed 24938534Richie JP Jr, Das A, Calcagnotto AM, Sinha R, Neidig W, Liao J, Lengerich EJ, Berg A, Hartman TJ, Ciccarella A, Baker A, Kaag MG, Goodin S, DiPaola RS, El-Bayoumy K. Comparative effects of two different forms of selenium on oxidative stress biomarkers in healthy men: a randomized clinical trial. Cancer Prev Res (Phila). 2014 Aug;7(8):796-804. doi: 10.1158/1940-6207.CAPR-14-0042. Epub 2014 Jun 17.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karam El-Bayoumy, PhD principal investigator
Penn State College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing selenomethionine, low dose selenized-yeast and high dose selenized-yeast in people with Effect of Selenium on Oxidative Stress in Healthy Men, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers of oxidative stress (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01112449, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2015.