Selenium Supplementation of Patients With Cirrhosis

This study has been terminated.

(Insufficient funds to complete study.)

Sponsor:

Collaborator:

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

Information provided by (Responsible Party):

RBurk, Vanderbilt University

ClinicalTrials.gov Identifier:

NCT00271245

First received: December 29, 2005

Last updated: March 6, 2012

Last verified: March 2012

History of Changes

Purpose

The purpose of this study is to determine whether patients with liver cirrhosis can improve their selenium nutritional status by taking supplemental selenium.

Condition	Intervention
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

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Selenium Supplementation of Patients With Cirrhosis

Resource links provided by NLM:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Cirrhosis Liver Diseases

Drug Information available for: Selenomethionine

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

Plasma selenoprotein P, Plasma GPX-3 activity, Total plasma selenium [ Time Frame: 8 week ] [ Designated as safety issue: No ]

Enrollment:	99
Study Start Date:	February 2006
Study Completion Date:	March 2012
Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

liver disease
aged 18 or above

Exclusion Criteria:

substance abuse
renal failure

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00271245

Locations

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

Principal Investigator:

Raymond F Burk, M.D.

Vanderbilt University

More Information

No publications provided

Responsible Party:	RBurk, M.D., Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00271245 History of Changes
Other Study ID Numbers:	DK58763-c, R01DK058763, DK58763
Study First Received:	December 29, 2005
Last Updated:	March 6, 2012
Health Authority:	United States: Federal Government

Keywords provided by Vanderbilt University:

cirrhosis
liver disease
selenium

selenoproteins
selenoprotein P
biomarkers

Additional relevant MeSH terms:

Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes
Selenium
Trace Elements

Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on May 19, 2013

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