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Human Selenium Nutritional Requirement and Biomarkers in Health and Disease
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Vanderbilt University
Nashville, Tennessee, United States
Start Date
March 1, 2006
Primary Completion Date
March 1, 2012
Completion Date
March 1, 2012
Last Updated
March 7, 2012
99
ACTUAL participants
selenium
DIETARY_SUPPLEMENT
selenium
DIETARY_SUPPLEMENT
selenium
DIETARY_SUPPLEMENT
placebo
DIETARY_SUPPLEMENT
Lead Sponsor
Vanderbilt University
Collaborators
NCT05597488
NCT06932783
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06306963