Optimization of Selenoprotein P in Chinese Subjects
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ClinicalTrials.gov Identifier: NCT00428649 |
Recruitment Status
:
Completed
First Posted
: January 30, 2007
Last Update Posted
: March 7, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Selenium Deficiency | Dietary Supplement: 20 µg selenium Dietary Supplement: 40 µg selenium Dietary Supplement: 60 µg selenium Dietary Supplement: 80 µg selenium Dietary Supplement: 100 µg selenium Dietary Supplement: 120 µg selenium Dietary Supplement: placebo | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 98 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Optimization of Selenoprotein P in Chinese Subjects |
Study Start Date : | March 2007 |
Actual Primary Completion Date : | December 2007 |
Actual Study Completion Date : | October 2008 |
Arm | Intervention/treatment |
---|---|
Experimental: 1
20 µg selenium as selenomethionine
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Dietary Supplement: 20 µg selenium
20 µg selenium as selenomethionine
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Experimental: 2
40 µg selenium as selenomethionine
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Dietary Supplement: 40 µg selenium
40 µg selenium as selenomethionine
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Experimental: 3
60 µg selenium as selenomethionine
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Dietary Supplement: 60 µg selenium
60 µg selenium as selenomethionine
|
Experimental: 4
80 µg selenium as selenomethionine
|
Dietary Supplement: 80 µg selenium
80 µg selenium as selenomethionine
|
Experimental: 5
100 µg selenium as selenomethionine
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Dietary Supplement: 100 µg selenium
100 µg selenium as selenomethionine
|
Experimental: 6
120 µg selenium as selenomethionine
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Dietary Supplement: 120 µg selenium
120 µg selenium as selenomethionine
|
Placebo Comparator: 7
placebo
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Dietary Supplement: placebo
placebo
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- Plasma selenoprotein P levels at 0, 4, 8, 12, 16, 20, 24, 32, and 40 weeks [ Time Frame: 40 weeks ]
- 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 ]

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Ages Eligible for Study: | 17 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- aged 17 years or older
- healthy
- resident of Mianning County for at least 1 year
- hematocrit (PCV) of 30 or greater
Exclusion Criteria:
- subject has taken selenium supplements within the year prior to study
- subject plans to relocate during study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00428649
China, Sichuan | |
Sichuan Center for Disease Control and Prevention (Sichuan CDC) | |
Chengdu, Sichuan, China |
Principal Investigator: | Raymond F Burk, M.D. | Vanderbilt University | |
Study Director: | Yiming Xia, Ph.D. | Sichuan CDC, Chengdu |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | RBurk, M.D., Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00428649 History of Changes |
Other Study ID Numbers: |
DK58763-opt R01DK058763 ( U.S. NIH Grant/Contract ) |
First Posted: | January 30, 2007 Key Record Dates |
Last Update Posted: | March 7, 2012 |
Last Verified: | March 2012 |
Keywords provided by RBurk, Vanderbilt University:
Selenium supplements Selenoprotein P Optimization |
Additional relevant MeSH terms:
Selenium Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |
Physiological Effects of Drugs Trace Elements Micronutrients Growth Substances |