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Selenium Supplementation of Patients With Cirrhosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00212186
First Posted: September 21, 2005
Last Update Posted: March 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
RBurk, Vanderbilt University
September 19, 2005
September 21, 2005
March 7, 2012
October 1998
November 2003   (Final data collection date for primary outcome measure)
Plasma Selenium Biomarkers
Same as current
Complete list of historical versions of study NCT00212186 on ClinicalTrials.gov Archive Site
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Selenium Supplementation of Patients With Cirrhosis
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The purpose of this study is to determine whether patients with liver disease can improve their nutritional selenium status by taking supplemental selenium.

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.

Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
  • Healthy
  • Liver Cirrhosis
Drug: Selenium Supplements (essential nutrient)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
November 2003
November 2003   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00212186
DK54819
R01DK058763 ( U.S. NIH Grant/Contract )
1R03DK054819 ( U.S. NIH Grant/Contract )
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RBurk, Vanderbilt University
Vanderbilt University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Raymond F Burk, M.D. Vanderbilt University
Vanderbilt University
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP