Selenium Supplementation of Patients With Cirrhosis

Cirrhosis Clinical Trial

Official title:

Human Selenium Nutritional Requirement and Biomarkers in Health and Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00212212
• Other study ID #: DK58763
• Secondary ID: R01DK058763RO1 D
• Status: Terminated
• Phase: N/A
• First received: September 19, 2005
• Last updated: March 6, 2012
• Start date: March 2006
• Est. completion date: March 2012

Study information

• Verified date: March 2012
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 99
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adults with cirrhosis

Exclusion Criteria:

• Pregnancy or planning a pregnancy

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

Study Design

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

Related Conditions & MeSH terms

• Cirrhosis
• Liver Cirrhosis

Intervention

Dietary Supplement:
• selenium
200 µg selenium as selenate
• selenium
400 µg selenium as selenate
• selenium
200 µg selenium as selenomethionine
• placebo
placebo tablet

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma selenium biomarkers		4 and 8 weeks	No