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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK058763 | U.S. NIH Grant/Contract | View source | |
| DK58763 |
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Insufficient funds to complete study.
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The purpose of this study is to determine whether patients with liver cirrhosis can improve their selenium nutritional status by taking supplemental selenium.
Selenium is an essential nutrient. Selenium carries out its biological functions through selenoproteins. The liver converts dietary selenium to a form that can be used to make selenoproteins. Patients with cirrhosis have much lower selenium levels than healthy individuals. We hypothesize that patients with cirrhosis are unable to utilize dietary selenium for selenoprotein synthesis. These patients may benefit from another form of selenium: selenate.
We will compare the effects of two supplemental forms of selenium on plasma selenium levels in patients with cirrhosis. Patients will be randomized to receive either a placebo, 200 µg selenomethionine, 200 µg selenate or 400 µg selenate, daily, for 8 weeks. We will measure selenium levels in the blood at baseline, week 4 and week 8. We will determine which forms of selenium, if any, increased plasma selenium levels of the cirrhosis patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 200 µg selenium as selenate |
|
| 2 | Experimental | 400 µg selenium as selenate |
|
| 3 | Experimental | 200 µg selenium as selenomethionine |
|
| 4 | Placebo Comparator | placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 200 µg selenium as selenate | Dietary Supplement | 200 µg selenium as selenate |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma selenoprotein P, Plasma GPX-3 activity, Total plasma selenium | 8 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raymond F Burk, M.D. | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26468123 | Derived | Burk RF, Hill KE, Motley AK, Byrne DW, Norsworthy BK. Selenium deficiency occurs in some patients with moderate-to-severe cirrhosis and can be corrected by administration of selenate but not selenomethionine: a randomized controlled trial. Am J Clin Nutr. 2015 Nov;102(5):1126-33. doi: 10.3945/ajcn.115.110932. Epub 2015 Oct 14. |
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| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012643 | Selenium |
| D064586 | Selenic Acid |
| D012645 | Selenomethionine |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008903 | Minerals |
| D018036 |
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| 400 µg selenium as selenate |
| Dietary Supplement |
400 µg selenium as selenate |
|
| 200 µg selenium as selenomethionine | Dietary Supplement | 200 µg selenium as selenomethionine |
|
| Placebo | Dietary Supplement | Placebo |
|
| Selenium Compounds |
| D016566 | Organoselenium Compounds |
| D009930 | Organic Chemicals |
| D008715 | Methionine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |