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Selenium Supplementation of Patients With Cirrhosis

Primary Purpose

Liver Disease

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

200 µg selenium as selenate

400 µg selenium as selenate

200 µg selenium as selenomethionine

Placebo

About this trial

This is an interventional treatment trial for Liver Disease focused on measuring cirrhosis, liver disease, selenium, selenoproteins, selenoprotein P, biomarkers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: liver disease aged 18 or above Exclusion Criteria: substance abuse renal failure

Sites / Locations

Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

200 µg selenium as selenate

400 µg selenium as selenate

200 µg selenium as selenomethionine

placebo

Outcomes

Primary Outcome Measures

Plasma selenoprotein P, Plasma GPX-3 activity, Total plasma selenium

Secondary Outcome Measures

Full Information

NCT ID

NCT00271245

First Posted

December 29, 2005

Last Updated

March 6, 2012

Sponsor

Vanderbilt University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00271245

Brief Title

Selenium Supplementation of Patients With Cirrhosis

Official Title

Selenium Supplementation of Patients With Cirrhosis

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Terminated

Why Stopped

Insufficient funds to complete study.

Study Start Date

February 2006 (undefined)

Primary Completion Date

March 2012 (Actual)

Study Completion Date

March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt University

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Disease

Keywords

cirrhosis, liver disease, selenium, selenoproteins, selenoprotein P, biomarkers

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

99 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

200 µg selenium as selenate

Arm Title

Arm Type

Experimental

Arm Description

400 µg selenium as selenate

Arm Title

Arm Type

Experimental

Arm Description

200 µg selenium as selenomethionine

Arm Title

Arm Type

Placebo Comparator

Arm Description

placebo

Intervention Type

Dietary Supplement

Intervention Name(s)

200 µg selenium as selenate

Intervention Description

200 µg selenium as selenate

Intervention Type

Dietary Supplement

Intervention Name(s)

400 µg selenium as selenate

Intervention Description

400 µg selenium as selenate

Intervention Type

Dietary Supplement

Intervention Name(s)

200 µg selenium as selenomethionine

Intervention Description

200 µg selenium as selenomethionine

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Plasma selenoprotein P, Plasma GPX-3 activity, Total plasma selenium

Time Frame

8 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: liver disease aged 18 or above Exclusion Criteria: substance abuse renal failure

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Raymond F Burk, M.D.

Organizational Affiliation

Vanderbilt University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vanderbilt University Medical Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

26468123

Citation

Burk RF, Hill KE, Motley AK, Byrne DW, Norsworthy BK. Selenium deficiency occurs in some patients with moderate-to-severe cirrhosis and can be corrected by administration of selenate but not selenomethionine: a randomized controlled trial. Am J Clin Nutr. 2015 Nov;102(5):1126-33. doi: 10.3945/ajcn.115.110932. Epub 2015 Oct 14.

Results Reference

derived

Learn more about this trial

Selenium Supplementation of Patients With Cirrhosis

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