Selenium Supplementation of Patients With Cirrhosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00271245

Recruitment Status : Terminated (Insufficient funds to complete study.)

First Posted : December 30, 2005

Last Update Posted : March 7, 2012

Sponsor:

Collaborator:

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

Information provided by (Responsible Party):

RBurk, Vanderbilt University

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.

Condition or disease	Intervention/treatment	Phase
Liver Disease	Dietary Supplement: 200 µg selenium as selenate Dietary Supplement: 400 µg selenium as selenate Dietary Supplement: 200 µg selenium as selenomethionine Dietary Supplement: Placebo	Not Applicable

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 Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	99 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Selenium Supplementation of Patients With Cirrhosis
Study Start Date :	February 2006
Actual Primary Completion Date :	March 2012
Actual Study Completion Date :	March 2012

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Cirrhosis

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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
Placebo Comparator: 4 placebo	Dietary Supplement: Placebo Placebo

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

liver disease
aged 18 or above

Exclusion Criteria:

substance abuse
renal failure

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00271245

Locations

Layout table for location information

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

Sponsors and Collaborators

Vanderbilt University

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

Investigators

Layout table for investigator information

Principal Investigator:	Raymond F Burk, M.D.	Vanderbilt University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Layout table for additonal information

Responsible Party:	RBurk, M.D., Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00271245
Other Study ID Numbers:	DK58763-c R01DK058763 ( U.S. NIH Grant/Contract ) DK58763
First Posted:	December 30, 2005 Key Record Dates
Last Update Posted:	March 7, 2012
Last Verified:	March 2012

Keywords provided by RBurk, Vanderbilt University:


cirrhosis liver disease selenium	selenoproteins selenoprotein P biomarkers

Additional relevant MeSH terms:

Layout table for MeSH terms

Liver Cirrhosis Liver Diseases Fibrosis Pathologic Processes Digestive System Diseases Selenium Selenic Acid	Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Trace Elements Micronutrients

To Top