Viewing Study NCT00212186



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Last Modification Date: 2024-10-26 @ 9:18 AM
Study NCT ID: NCT00212186
Status: COMPLETED
Last Update Posted: 2012-03-07
First Post: 2005-09-19

Brief Title: Selenium Supplementation of Patients With Cirrhosis
Sponsor: Vanderbilt University
Organization: Vanderbilt University

Study Overview

Official Title: None
Status: COMPLETED
Status Verified Date: 2012-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
1R03DK054819 NIH None httpsreporternihgovquickSearch1R03DK054819
R01DK058763 NIH None None