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Selenium Supplementation of Patients With Cirrhosis

Information source: Vanderbilt University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cirrhosis

Intervention: selenium (Dietary Supplement); selenium (Dietary Supplement); selenium (Dietary Supplement); placebo (Dietary Supplement)

Phase: N/A

Status: Terminated

Sponsored by: Vanderbilt University

Official(s) and/or principal investigator(s):
Raymond F Burk, M.D., Principal Investigator, Affiliation: Vanderbilt University


This study is being conducted to determine if patients with cirrhosis (liver disease) are selenium deficient. The effect of supplementation with two chemical forms of selenium on plasma selenium biomarkers will be determined and correlated with the severity of the liver disease.

Clinical Details

Official title: Human Selenium Nutritional Requirement and Biomarkers in Health and Disease

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic

Primary outcome: Plasma selenium biomarkers

Detailed description: Selenium is an essential nutrient that plays a role in oxidant defense, among other functions. There is much interest in the role selenium may play in several disease processes. It is possible that certain diseases result in selenium deficiency because of the form of selenium taken in the normal diet. We propose to measure the selenium biomarkers associated with supplemental intakes of 200 or 400 µg of selenium per day in the chemical form selenate, or with supplemental intake of 200 µg selenium as selenomethionine. 144 patients with cirrhosis will be randomized to one of 4 treatment groups, including a placebo. After treatement for 4 weeks, all participants will receive 400 µg of selenium per day as selenate for 4 weeks. Blood will be measured initially and at 4 and 8 weeks. Selenium, selenoprotein P and glutathione peroxidase will be measured in the plasma.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- adults with cirrhosis

Exclusion Criteria:

- Pregnancy or planning a pregnancy

- Selenium supplements of 25 µg or more within the past year

Locations and Contacts

Vanderbilt University, Nashville, Tennessee 37232, United States
Additional Information

Starting date: March 2006
Last updated: March 6, 2012

Page last updated: August 23, 2015

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