NCT00212212

Selenium Supplementation of Patients With Cirrhosis

Human Selenium Nutritional Requirement and Biomarkers in Health and Disease

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Cirrhosis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	selenium	200 µg selenium as selenate
DIETARY_SUPPLEMENT	selenium	400 µg selenium as selenate
DIETARY_SUPPLEMENT	selenium	200 µg selenium as selenomethionine
DIETARY_SUPPLEMENT	placebo	placebo tablet

Timeline

• Start date: 2006-03-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2005-09-21
• Last updated: 2012-03-07

Locations

1 site across 1 country: United States