Selenium Supplementation of Patients With Cirrhosis

Not Applicable

Terminated

• Conditions: Liver Disease
• Interventions: Dietary Supplement: 200 µg selenium as selenate; Dietary Supplement: 400 µg selenium as selenate; Dietary Supplement: 200 µg selenium as selenomethionine; Dietary Supplement: Placebo

• Registration Number: NCT00271245
• Lead Sponsor: Vanderbilt University

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2005-12-29
• Study First Submitted QC: 2005-12-29
• Study First Posted: 2005-12-30
• Study Start: 2006-02
• Status Verified: 2012-03
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Last Update Submitted: 2012-03-06
• Last Update Posted: 2012-03-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

• liver disease
• aged 18 or above

Exclusion Criteria

• substance abuse
• renal failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	200 µg selenium as selenate	200 µg selenium as selenate
2	400 µg selenium as selenate	400 µg selenium as selenate
3	200 µg selenium as selenomethionine	200 µg selenium as selenomethionine
4	Placebo	placebo

Primary Outcome Measures

Name	Time	Method
Plasma selenoprotein P, Plasma GPX-3 activity, Total plasma selenium	8 week

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States