Selenium Supplementation of Patients With Cirrhosis
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ClinicalTrials.gov Identifier: NCT00212186 |
Recruitment Status
:
Completed
First Posted
: September 21, 2005
Last Update Posted
: March 7, 2012
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy Liver Cirrhosis | Drug: Selenium Supplements (essential nutrient) | Not Applicable |
Selenium is an essential nutrient. Selenium carries out its biological functions through selenoproteins. The most abundant selenoprotein in the plasma is selenoprotein P, which is largely synthesized in the liver. Patients with liver disease often have less than half the selenoprotein P levels of normal individuals. This suggests that people with liver disease are not meeting their selenium requirements and may benefit from additional selenium.
We proposed to compare the effects of two different forms of supplemental selenium on plasma selenium levels among patients with severe liver cirrhosis and healthy individuals (controls). Patients and controls were randomly assigned to one of 3 treatment groups: 200 µg selenium per day as selenate, 200 µg selenium per day as selenomethionine, or a placebo. The intervention lasted 8 weeks. Blood was measured initially and after 2 and 4 weeks of supplementation. Selenium, selenoprotein P and glutathione peroxidase were measured in the plasma. We compared changes in selenium and selenoprotein levels between liver cirrhosis patients and healthy controls.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 48 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Study Start Date : | October 1998 |
Actual Primary Completion Date : | November 2003 |
Actual Study Completion Date : | November 2003 |

- Plasma Selenium Biomarkers

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy Adults
- Adults with Child-Pugh Class C liver cirrhosis
Exclusion Criteria:
- Diagnosis of renal failure
- Urgent need of liver transplant
- Selenium supplements of >25 µg per day during the past year

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): NCT00212186
United States, Tennessee | |
Vanderbilt University Medical Center | |
Nashville, Tennessee, United States, 37232 |
Principal Investigator: | Raymond F Burk, M.D. | Vanderbilt University |
Responsible Party: | RBurk, M.D., Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00212186 History of Changes |
Other Study ID Numbers: |
DK54819 R01DK058763 ( U.S. NIH Grant/Contract ) 1R03DK054819 ( U.S. NIH Grant/Contract ) |
First Posted: | September 21, 2005 Key Record Dates |
Last Update Posted: | March 7, 2012 |
Last Verified: | March 2012 |
Additional relevant MeSH terms:
Fibrosis Liver Cirrhosis Pathologic Processes Liver Diseases Digestive System Diseases Selenium Antioxidants |
Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Trace Elements Micronutrients Growth Substances |