ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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 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 related topics: Cirrhosis

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




Primary Outcome Measures :
  1. Plasma selenoprotein P, Plasma GPX-3 activity, Total plasma selenium [ Time Frame: 8 week ]


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.


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

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
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: RBurk, M.D., Vanderbilt University
ClinicalTrials.gov Identifier: NCT00271245     History of Changes
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:
Selenium
Fibrosis
Liver Cirrhosis
Liver Diseases
Pathologic Processes
Digestive System Diseases
Selenic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Growth Substances