Selenium DeficiencyNCT00428649
Optimization of Selenoprotein P in Chinese Subjects
A study testing 20 µg selenium, 40 µg selenium and 60 µg selenium in people with Selenium Deficiency, run by Vanderbilt University at 1 site in China.
Trial summary
The purpose of this study is to determine the amount of selenium as selenomethionine that is required to optimize selenoprotein P in selenium-deficient Chinese subjects Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Selenium Deficiency
- What is being tested?
- 20 µg selenium, 40 µg selenium and 60 µg selenium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- Mar 2007to Oct 2008
- 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 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- aged 17 years or older
- healthy
- resident of Mianning County for at least 1 year
- hematocrit (PCV) of 30 or greater
Who cannot join
- subject has taken selenium supplements within the year prior to study
- subject plans to relocate during study
Trial locations and contacts
1 site in 1 country.
China1 site
Sichuan Center for Disease Control and Prevention (Sichuan CDC)
Chengdu, Sichuan
About this study
The purpose of this study is to determine the amount of selenium as selenomethionine that is required to optimize selenoprotein P in selenium-deficient Chinese subjects
Read the detailed description
Selenium is an essential nutrient. The Recommended Dietary Allowance (RDA) for selenium is considered to be the amount required to optimize plasma selenoproteins. There are two selenoproteins present in the plasma: selenoprotein P (Se-P) and glutathione peroxidase 3 (GPX-3). Although the amount of selenium required to optimize GPX-3 has been determined, the amount required to optimize Se-P in the plasma remains unknown. We aim to determine this amount by supplementing selenium deficient subjects with varying amounts of selenium as selenomethionine.
The study will take place in Mianning County, China, where selenium status is low. Approximately 150 people will be screened for eligibility to participate in this study. 98 subjects will be enrolled. Background information obtained from each participant will be: age, height, weight and smoking status.
Subjects will be randomized to a selenium supplement group. The selenium supplement will contain either 0, 20, 40, 60, 80, 100, or 120 µg of selenium as selenomethionine. A CDC worker will visit each participant daily to give them their selenium supplement. The CDC worker will watch them take their supplement and will ask if they have any unanticipated problems. Blood samples of 20 ml will be obtained at weeks 0, 4, 8, 12, 16, 20, 24, 32, and 40. Hair samples and 24-hr urine collections will be obtained at 0, 20 and 40 weeks. The total study duration is 40 weeks.
- Conditions
- Selenium Deficiency
- Being tested
- 20 µg selenium, 40 µg selenium, 60 µg selenium, 80 µg selenium, 100 µg selenium
- Keywords
- Selenium supplements, Selenoprotein P, Optimization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20 µg seleniumDietary supplement
20 µg selenium as selenomethionine
40 µg seleniumDietary supplement
40 µg selenium as selenomethionine
60 µg seleniumDietary supplement
60 µg selenium as selenomethionine
80 µg seleniumDietary supplement
80 µg selenium as selenomethionine
100 µg seleniumDietary supplement
100 µg selenium as selenomethionine
120 µg seleniumDietary supplement
120 µg selenium as selenomethionine
placeboDietary supplement
placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 20 µg selenium as selenomethionine Receives: Dietary Supplement: 20 µg selenium |
| 2 | Experimental | 40 µg selenium as selenomethionine Receives: Dietary Supplement: 40 µg selenium |
| 3 | Experimental | 60 µg selenium as selenomethionine Receives: Dietary Supplement: 60 µg selenium |
| 4 | Experimental | 80 µg selenium as selenomethionine Receives: Dietary Supplement: 80 µg selenium |
| 5 | Experimental | 100 µg selenium as selenomethionine Receives: Dietary Supplement: 100 µg selenium |
| 6 | Experimental | 120 µg selenium as selenomethionine Receives: Dietary Supplement: 120 µg selenium |
| 7 | Placebo comparator | placebo Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma selenoprotein P levels at 0, 4, 8, 12, 16, 20, 24, 32, and 40 weeks
Measured: 40 weeks
Secondary outcomes (4)
Total plasma selenium concentrations at 0, 4, 8, 12, 16, 20, 24, 32, and 40 weeks
Measured: 40 weeks
Plasma glutathione peroxidase activity at 0, 4, 8, 12, 16, 20, 24, 32, and 40 weeks
Measured: 40 weeks
24hr urinary selenium excretion at 0, 20 and 40 weeks
Measured: 40 weeks
Hair selenium levels at 0, 20 and 40 weeks
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2007 (estimated)
- Study startMar 2007
- Primary completionDec 2007
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Selenium DeficiencyStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RBurk, Vanderbilt University
- Investigators
- Raymond F Burk, M.D., Principal investigator, Vanderbilt UniversityYiming Xia, Ph.D., Study director, Sichuan CDC, Chengdu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00428649
- Sponsor's protocol ID
- DK58763-opt
- Other IDs
- R01DK058763
- Status last verified
- Mar 2012
- First submitted
- 25 Jan 2007
- Last updated
- 7 Mar 2012
- Results posted
- No
Publications
Xia Y, Hill KE, Byrne DW, Xu J, Burk RF. Effectiveness of selenium supplements in a low-selenium area of China. Am J Clin Nutr. 2005 Apr;81(4):829-34. doi: 10.1093/ajcn/81.4.829.
PubMed 15817859Casey CE, Guthrie BE, Friend GM, Robinson MF. Selenium in human tissues from New Zealand. Arch Environ Health. 1982 May-Jun;37(3):133-5. doi: 10.1080/00039896.1982.10667551.
PubMed 7092329Xia Y, Hill KE, Li P, Xu J, Zhou D, Motley AK, Wang L, Byrne DW, Burk RF. Optimization of selenoprotein P and other plasma selenium biomarkers for the assessment of the selenium nutritional requirement: a placebo-controlled, double-blind study of selenomethionine supplementation in selenium-deficient Chinese subjects. Am J Clin Nutr. 2010 Sep;92(3):525-31. doi: 10.3945/ajcn.2010.29642. Epub 2010 Jun 23.
PubMed 20573787
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Selenoprotein P in Chinese Subjects
- ClinicalTrials.gov ID
- NCT00428649
- Acronym / sponsor ID
- DK58763-opt
- Conditions
- Selenium Deficiency
- Keywords
- Selenium supplements, Selenoprotein P, Optimization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Mar 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 30 Jan 2007 (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.
The purpose of this study is to determine the amount of selenium as selenomethionine that is required to optimize selenoprotein P in selenium-deficient Chinese subjects
Detailed description
Selenium is an essential nutrient. The Recommended Dietary Allowance (RDA) for selenium is considered to be the amount required to optimize plasma selenoproteins. There are two selenoproteins present in the plasma: selenoprotein P (Se-P) and glutathione peroxidase 3 (GPX-3). Although the amount of selenium required to optimize GPX-3 has been determined, the amount required to optimize Se-P in the plasma remains unknown. We aim to determine this amount by supplementing selenium deficient subjects with varying amounts of selenium as selenomethionine.
The study will take place in Mianning County, China, where selenium status is low. Approximately 150 people will be screened for eligibility to participate in this study. 98 subjects will be enrolled. Background information obtained from each participant will be: age, height, weight and smoking status.
Subjects will be randomized to a selenium supplement group. The selenium supplement will contain either 0, 20, 40, 60, 80, 100, or 120 µg of selenium as selenomethionine. A CDC worker will visit each participant daily to give them their selenium supplement. The CDC worker will watch them take their supplement and will ask if they have any unanticipated problems. Blood samples of 20 ml will be obtained at weeks 0, 4, 8, 12, 16, 20, 24, 32, and 40. Hair samples and 24-hr urine collections will be obtained at 0, 20 and 40 weeks. The total study duration is 40 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: 20 µg selenium20 µg selenium as selenomethionine |
| 2 | Experimental | Dietary Supplement: 40 µg selenium40 µg selenium as selenomethionine |
| 3 | Experimental | Dietary Supplement: 60 µg selenium60 µg selenium as selenomethionine |
| 4 | Experimental | Dietary Supplement: 80 µg selenium80 µg selenium as selenomethionine |
| 5 | Experimental | Dietary Supplement: 100 µg selenium100 µg selenium as selenomethionine |
| 6 | Experimental | Dietary Supplement: 120 µg selenium120 µg selenium as selenomethionine |
| 7 | Placebo comparator | Dietary Supplement: placeboplacebo |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- aged 17 years or older
- healthy
- resident of Mianning County for at least 1 year
- hematocrit (PCV) of 30 or greater
Key exclusion criteria (2 listed)
- subject has taken selenium supplements within the year prior to study
- subject plans to relocate during study
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 |
|---|---|---|
| 20 µg selenium20 µg selenium as selenomethionine | Dietary supplement | 1 |
| 40 µg selenium40 µg selenium as selenomethionine | Dietary supplement | 2 |
| 60 µg selenium60 µg selenium as selenomethionine | Dietary supplement | 3 |
| 80 µg selenium80 µg selenium as selenomethionine | Dietary supplement | 4 |
| 100 µg selenium100 µg selenium as selenomethionine | Dietary supplement | 5 |
| 120 µg selenium120 µg selenium as selenomethionine | Dietary supplement | 6 |
| placeboplacebo | Dietary supplement | 7 |
Primary outcome
Plasma selenoprotein P levels at 0, 4, 8, 12, 16, 20, 24, 32, and 40 weeks
Time frame: 40 weeks
4 secondary outcomes
Total plasma selenium concentrations at 0, 4, 8, 12, 16, 20, 24, 32, and 40 weeks
Time frame: 40 weeks
Plasma glutathione peroxidase activity at 0, 4, 8, 12, 16, 20, 24, 32, and 40 weeks
Time frame: 40 weeks
24hr urinary selenium excretion at 0, 20 and 40 weeks
Time frame: 40 weeks
Hair selenium levels at 0, 20 and 40 weeks
Time frame: 40 weeks
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 7 Mar 2012.
- Background: PubMed 15817859Xia Y, Hill KE, Byrne DW, Xu J, Burk RF. Effectiveness of selenium supplements in a low-selenium area of China. Am J Clin Nutr. 2005 Apr;81(4):829-34. doi: 10.1093/ajcn/81.4.829.
- Background: PubMed 7092329Casey CE, Guthrie BE, Friend GM, Robinson MF. Selenium in human tissues from New Zealand. Arch Environ Health. 1982 May-Jun;37(3):133-5. doi: 10.1080/00039896.1982.10667551.
- Derived from this study: PubMed 20573787Xia Y, Hill KE, Li P, Xu J, Zhou D, Motley AK, Wang L, Byrne DW, Burk RF. Optimization of selenoprotein P and other plasma selenium biomarkers for the assessment of the selenium nutritional requirement: a placebo-controlled, double-blind study of selenomethionine supplementation in selenium-deficient Chinese subjects. Am J Clin Nutr. 2010 Sep;92(3):525-31. doi: 10.3945/ajcn.2010.29642. Epub 2010 Jun 23.
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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.
Raymond F Burk, M.D. principal investigator
Vanderbilt University
Yiming Xia, Ph.D. study director
Sichuan CDC, Chengdu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 20 µg selenium, 40 µg selenium and 60 µg selenium in people with Selenium Deficiency, run by Vanderbilt University at 1 site in China.
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 4 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 7 Mar 2012. 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 China. 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?
Plasma selenoprotein P levels at 0, 4, 8, 12, 16, 20, 24, 32, and 40 weeks (time frame: 40 weeks). 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 NCT00428649, which also lists 3 linked publications.
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 7 Mar 2012.