Selenium Supplementation of Patients With Cirrhosis
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About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- adults with cirrhosis
Exclusion criteria
- Pregnancy or planning a pregnancy
- Selenium supplements of 25 µg or more within the past year
Trial design
Primary purpose
Allocation
Interventional model
Masking
99 participants in 4 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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