Selenium Supplementation of Patients With Cirrhosis

March 6, 2012 updated by: RBurk, Vanderbilt University
The purpose of this study is to determine whether patients with liver cirrhosis can improve their selenium nutritional status by taking supplemental selenium.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

99

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • liver disease
  • aged 18 or above

Exclusion Criteria:

  • substance abuse
  • renal failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 4
placebo
Dietary supplement: Placebo
Placebo
Experimental: 1
200 µg selenium as selenate
Dietary supplement: 200 µg selenium as selenate
200 µg selenium as selenate
Experimental: 2
400 µg selenium as selenate
Dietary supplement: 400 µg selenium as selenate
400 µg selenium as selenate
Experimental: 3
200 µg selenium as selenomethionine
Dietary supplement: 200 µg selenium as selenomethionine
200 µg selenium as selenomethionine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma selenoprotein P, Plasma GPX-3 activity, Total plasma selenium
Time Frame: 8 week
8 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

December 29, 2005

First Submitted That Met QC Criteria

December 29, 2005

First Posted (Estimate)

December 30, 2005

Study Record Updates

Last Update Posted (Estimate)

March 7, 2012

Last Update Submitted That Met QC Criteria

March 6, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DK58763-c
  • R01DK058763 (U.S. NIH Grant/Contract)
  • DK58763

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe