Selenium Supplementation of Patients With Cirrhosis

This study has been terminated.
(Insufficient funds to complete study.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
RBurk, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00212212
First received: September 19, 2005
Last updated: March 6, 2012
Last verified: March 2012
  Purpose

This study is being conducted to determine if patients with cirrhosis (liver disease) are selenium deficient. The effect of supplementation with two chemical forms of selenium on plasma selenium biomarkers will be determined and correlated with the severity of the liver disease.


Condition Intervention
Cirrhosis
Dietary Supplement: selenium
Dietary Supplement: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
Official Title: Human Selenium Nutritional Requirement and Biomarkers in Health and Disease

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Plasma selenium biomarkers [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 99
Study Start Date: March 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: selenium
200 µg selenium as selenate
Experimental: 2
400 µg selenium as selenate
Dietary Supplement: selenium
400 µg selenium as selenate
Experimental: 3
200 µg selenium as selenomethionine
Dietary Supplement: selenium
200 µg selenium as selenomethionine
Placebo Comparator: 4
placebo tablet
Dietary Supplement: placebo
placebo tablet

Detailed Description:

Selenium is an essential nutrient that plays a role in oxidant defense, among other functions. There is much interest in the role selenium may play in several disease processes. It is possible that certain diseases result in selenium deficiency because of the form of selenium taken in the normal diet.

We propose to measure the selenium biomarkers associated with supplemental intakes of 200 or 400 µg of selenium per day in the chemical form selenate, or with supplemental intake of 200 µg selenium as selenomethionine. 144 patients with cirrhosis will be randomized to one of 4 treatment groups, including a placebo. After treatement for 4 weeks, all participants will receive 400 µg of selenium per day as selenate for 4 weeks. Blood will be measured initially and at 4 and 8 weeks. Selenium, selenoprotein P and glutathione peroxidase will be measured in the plasma.

  Eligibility

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

Inclusion Criteria:

  • adults with cirrhosis

Exclusion Criteria:

  • Pregnancy or planning a pregnancy
  • Selenium supplements of 25 µg or more within 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: NCT00212212

Locations
United States, Tennessee
Vanderbilt University
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: NCT00212212     History of Changes
Other Study ID Numbers: DK58763, R01DK058763, RO1 DK58763-06
Study First Received: September 19, 2005
Last Updated: March 6, 2012
Health Authority: United States: Federal Government

Keywords provided by Vanderbilt University:
selenium supplements
selenate
selenomethionine
biomarkers
plasma selenium concentration
plasma glutathione peroxidase
selenoprotein P

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 July 23, 2014