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
|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|
|Intervention Model:||Parallel Assignment|
|Study Start Date :||October 1998|
|Actual Primary Completion Date :||November 2003|
|Actual Study Completion Date :||November 2003|
- Plasma Selenium Biomarkers
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|