Selenium Supplementation of Patients With Cirrhosis
- Conditions
- HealthyLiver Cirrhosis
- Registration Number
- NCT00212186
- Lead Sponsor
- Vanderbilt University
- Brief Summary
The purpose of this study is to determine whether patients with liver disease can improve their nutritional selenium status by taking supplemental selenium.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- Healthy Adults
- Adults with Child-Pugh Class C liver cirrhosis
- Diagnosis of renal failure
- Urgent need of liver transplant
- Selenium supplements of >25 µg per day during the past year
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Plasma Selenium Biomarkers
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States