Selenium Supplementation of Patients With Cirrhosis

Not Applicable

Terminated

• Conditions: Cirrhosis
• Interventions: Dietary Supplement: selenium; Dietary Supplement: placebo

• Registration Number: NCT00212212
• Lead Sponsor: Vanderbilt University

Brief 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.

Study Timeline

• Study First Submitted: 2005-09-19
• Study First Submitted QC: 2005-09-19
• Study First Posted: 2005-09-21
• Study Start: 2006-03
• 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

• adults with cirrhosis

Exclusion Criteria

• Pregnancy or planning a pregnancy
• Selenium supplements of 25 µg or more within the past year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Plasma selenium biomarkers	4 and 8 weeks

Trial Locations

Locations (1)

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States