- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00212186
Selenium Supplementation of Patients With Cirrhosis
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Plasma Selenium Biomarkers
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DK54819
- R01DK058763 (U.S. NIH Grant/Contract)
- 1R03DK054819 (U.S. NIH Grant/Contract)
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