Selenium Supplementation of Patients With Cirrhosis

• ClinicalTrials.gov Identifier: NCT00271245
• Recruitment Status: Terminated
• First Posted: December 30, 2005
• Last Update Posted: March 7, 2012
• Sponsor: Vanderbilt University
• 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

• 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

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 :

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

Eligibility Criteria

• 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

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

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.

• 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
• 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:

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