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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK058763 | U.S. NIH Grant/Contract | View source | |
| R01DK058763-06 | U.S. NIH Grant/Contract | View source |
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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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This study is being conducted to determine if patients with cirrhosis (liver disease) are selenium deficient. The effect of supplementation with two chemical forms of selenium on plasma selenium biomarkers will be determined and correlated with the severity of the liver disease.
Selenium is an essential nutrient that plays a role in oxidant defense, among other functions. There is much interest in the role selenium may play in several disease processes. It is possible that certain diseases result in selenium deficiency because of the form of selenium taken in the normal diet.
We propose to measure the selenium biomarkers associated with supplemental intakes of 200 or 400 µg of selenium per day in the chemical form selenate, or with supplemental intake of 200 µg selenium as selenomethionine. 144 patients with cirrhosis will be randomized to one of 4 treatment groups, including a placebo. After treatement for 4 weeks, all participants will receive 400 µg of selenium per day as selenate for 4 weeks. Blood will be measured initially and at 4 and 8 weeks. Selenium, selenoprotein P and glutathione peroxidase will be measured in the plasma.
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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 |
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| 4 | Placebo Comparator | placebo tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| selenium | Dietary Supplement | 200 µg selenium as selenate |
| |
| selenium |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma selenium biomarkers | 4 and 8 weeks |
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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 | Nashville | Tennessee | 37232 | United States |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012643 | Selenium |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008903 | Minerals |
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| Dietary Supplement |
400 µg selenium as selenate |
|
| selenium | Dietary Supplement | 200 µg selenium as selenomethionine |
|
| placebo | Dietary Supplement | placebo tablet |
|