Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01DK058763 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 20 µg selenium as selenomethionine |
|
| 2 | Experimental | 40 µg selenium as selenomethionine |
|
| 3 | Experimental | 60 µg selenium as selenomethionine |
|
| 4 | Experimental | 80 µg selenium as selenomethionine |
|
| 5 | Experimental | 100 µg selenium as selenomethionine |
|
| 6 | Experimental | 120 µg selenium as selenomethionine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 20 µg selenium | Dietary Supplement | 20 µg selenium as selenomethionine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma selenoprotein P levels at 0, 4, 8, 12, 16, 20, 24, 32, and 40 weeks | 40 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Total plasma selenium concentrations at 0, 4, 8, 12, 16, 20, 24, 32, and 40 weeks | 40 weeks | |
| Plasma glutathione peroxidase activity at 0, 4, 8, 12, 16, 20, 24, 32, and 40 weeks | 40 weeks | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Raymond F Burk, M.D. | Vanderbilt University | Principal Investigator |
| Yiming Xia, Ph.D. | Sichuan CDC, Chengdu | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Center for Disease Control and Prevention (Sichuan CDC) | Chengdu | Sichuan | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15817859 | Background | 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. | |
| 7092329 | Background | Casey 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012643 | Selenium |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008903 | Minerals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 7 | Placebo Comparator | placebo |
|
| 40 µg selenium |
| Dietary Supplement |
40 µg selenium as selenomethionine |
|
| 60 µg selenium | Dietary Supplement | 60 µg selenium as selenomethionine |
|
| 80 µg selenium | Dietary Supplement | 80 µg selenium as selenomethionine |
|
| 100 µg selenium | Dietary Supplement | 100 µg selenium as selenomethionine |
|
| 120 µg selenium | Dietary Supplement | 120 µg selenium as selenomethionine |
|
| placebo | Dietary Supplement | placebo |
|
| 24hr urinary selenium excretion at 0, 20 and 40 weeks |
| 40 weeks |
| Hair selenium levels at 0, 20 and 40 weeks | 40 weeks |
| 20573787 | Derived | Xia 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. |