Selenium Supplementation of Patients With Cirrhosis

March 6, 2012 updated by: RBurk, Vanderbilt University

Human Selenium Nutritional Requirement and Biomarkers in Health and Disease

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 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

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:

  • adults with cirrhosis

Exclusion Criteria:

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

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: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
200 µg selenium as selenate
Dietary supplement: selenium
200 µg selenium as selenate
Dietary supplement: selenium
400 µg selenium as selenate
Dietary supplement: selenium
200 µg selenium as selenomethionine
EXPERIMENTAL: 2
400 µg selenium as selenate
Dietary supplement: selenium
200 µg selenium as selenate
Dietary supplement: selenium
400 µg selenium as selenate
Dietary supplement: selenium
200 µg selenium as selenomethionine
EXPERIMENTAL: 3
200 µg selenium as selenomethionine
Dietary supplement: selenium
200 µg selenium as selenate
Dietary supplement: selenium
400 µg selenium as selenate
Dietary supplement: selenium
200 µg selenium as selenomethionine
PLACEBO_COMPARATOR: 4
placebo tablet
Dietary supplement: placebo
placebo tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma selenium biomarkers
Time Frame: 4 and 8 weeks
4 and 8 weeks

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)

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

March 1, 2006

Primary Completion (ACTUAL)

March 1, 2012

Study Completion (ACTUAL)

March 1, 2012

Study Registration Dates

First Submitted

September 19, 2005

First Submitted That Met QC Criteria

September 19, 2005

First Posted (ESTIMATE)

September 21, 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
  • R01DK058763 (U.S. NIH Grant/Contract)
  • R01DK058763-06 (NIH)

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.

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