Selenium Supplementation of Patients With Cirrhosis

Liver Disease Clinical Trial

Official title:

Selenium Supplementation of Patients With Cirrhosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00271245
• Other study ID #: DK58763-c
• Secondary ID: R01DK058763DK587
• Status: Terminated
• Phase: N/A
• First received: December 29, 2005
• Last updated: March 6, 2012
• Start date: February 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

The purpose of this study is to determine whether patients with liver cirrhosis can improve their selenium nutritional status by taking supplemental selenium.

Description:

Selenium is an essential nutrient. Selenium carries out its biological functions through selenoproteins. The liver converts dietary selenium to a form that can be used to make selenoproteins. Patients with cirrhosis have much lower selenium levels than healthy individuals. We hypothesize that patients with cirrhosis are unable to utilize dietary selenium for selenoprotein synthesis. These patients may benefit from another form of selenium: selenate.

We will compare the effects of two supplemental forms of selenium on plasma selenium levels in patients with cirrhosis. Patients will be randomized to receive either a placebo, 200 µg selenomethionine, 200 µg selenate or 400 µg selenate, daily, for 8 weeks. We will measure selenium levels in the blood at baseline, week 4 and week 8. We will determine which forms of selenium, if any, increased plasma selenium levels of the cirrhosis patients.

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:

• liver disease

• aged 18 or above

Exclusion Criteria:

• substance abuse

• renal failure

Study Design

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

Related Conditions & MeSH terms

• Liver Disease
• Liver Diseases

Intervention

Dietary Supplement:
• 200 µg selenium as selenate
200 µg selenium as selenate
• 400 µg selenium as selenate
400 µg selenium as selenate
• 200 µg selenium as selenomethionine
200 µg selenium as selenomethionine
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	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 selenoprotein P, Plasma GPX-3 activity, Total plasma selenium		8 week	No