Selenium Supplementation of Patients With Cirrhosis

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
RBurk, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00212186
First received: September 19, 2005
Last updated: March 6, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention
Healthy
Liver Cirrhosis
Drug: Selenium Supplements (essential nutrient)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Plasma Selenium Biomarkers

Enrollment: 48
Study Start Date: October 1998
Study Completion Date: November 2003
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
Detailed Description:

Selenium is an essential nutrient. Selenium carries out its biological functions through selenoproteins. The most abundant selenoprotein in the plasma is selenoprotein P, which is largely synthesized in the liver. Patients with liver disease often have less than half the selenoprotein P levels of normal individuals. This suggests that people with liver disease are not meeting their selenium requirements and may benefit from additional selenium.

We proposed to compare the effects of two different forms of supplemental selenium on plasma selenium levels among patients with severe liver cirrhosis and healthy individuals (controls). Patients and controls were randomly assigned to one of 3 treatment groups: 200 µg selenium per day as selenate, 200 µg selenium per day as selenomethionine, or a placebo. The intervention lasted 8 weeks. Blood was measured initially and after 2 and 4 weeks of supplementation. Selenium, selenoprotein P and glutathione peroxidase were measured in the plasma. We compared changes in selenium and selenoprotein levels between liver cirrhosis patients and healthy controls.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Adults
  • Adults with Child-Pugh Class C liver cirrhosis

Exclusion Criteria:

  • Diagnosis of renal failure
  • Urgent need of liver transplant
  • Selenium supplements of >25 µg per day during the past year
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00212186

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
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: NCT00212186     History of Changes
Other Study ID Numbers: DK54819, R01DK058763, 1RO3 DK54819
Study First Received: September 19, 2005
Last Updated: March 6, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Liver Cirrhosis
Digestive System Diseases
Liver Diseases
Selenium
Antioxidants
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Trace Elements

ClinicalTrials.gov processed this record on October 20, 2014