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