An interventional study of 20 µg selenium and 40 µg selenium in Selenium Deficiency, sponsored by Vanderbilt University. Completed at 1 site in China. Open to participants aged 17 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-03-07.
Sponsored by Vanderbilt University · Not applicable, Interventional, and Prevention
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.
Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
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Exclusion Criteria:
20 µg selenium as selenomethionine
Dietary Supplement: 20 µg selenium
40 µg selenium as selenomethionine
Dietary Supplement: 40 µg selenium
60 µg selenium as selenomethionine
Dietary Supplement: 60 µg selenium
80 µg selenium as selenomethionine
Dietary Supplement: 80 µg selenium
100 µg selenium as selenomethionine
Dietary Supplement: 100 µg selenium
120 µg selenium as selenomethionine
Dietary Supplement: 120 µg selenium
placebo
Dietary Supplement: placebo
20 µg selenium as selenomethionine
40 µg selenium as selenomethionine
60 µg selenium as selenomethionine
80 µg selenium as selenomethionine
100 µg selenium as selenomethionine
120 µg selenium as selenomethionine
placebo
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
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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