Selenium Supplementation of Patients With Cirrhosis
Primary Purpose
Cirrhosis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
selenium
selenium
selenium
placebo
Sponsored by
About this trial
This is an interventional diagnostic trial for Cirrhosis focused on measuring selenium supplements, selenate, selenomethionine, biomarkers, plasma selenium concentration, plasma glutathione peroxidase, selenoprotein P
Eligibility Criteria
Inclusion Criteria: adults with cirrhosis Exclusion Criteria: Pregnancy or planning a pregnancy Selenium supplements of 25 µg or more within the past year
Sites / Locations
- Vanderbilt University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
1
2
3
4
Arm Description
200 µg selenium as selenate
400 µg selenium as selenate
200 µg selenium as selenomethionine
placebo tablet
Outcomes
Primary Outcome Measures
Plasma selenium biomarkers
Secondary Outcome Measures
Full Information
NCT ID
NCT00212212
First Posted
September 19, 2005
Last Updated
March 6, 2012
Sponsor
Vanderbilt University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT00212212
Brief Title
Selenium Supplementation of Patients With Cirrhosis
Official Title
Human Selenium Nutritional Requirement and Biomarkers in Health and Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Terminated
Why Stopped
Insufficient funds to complete study.
Study Start Date
March 2006 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis
Keywords
selenium supplements, selenate, selenomethionine, biomarkers, plasma selenium concentration, plasma glutathione peroxidase, selenoprotein P
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
200 µg selenium as selenate
Arm Title
2
Arm Type
Experimental
Arm Description
400 µg selenium as selenate
Arm Title
3
Arm Type
Experimental
Arm Description
200 µg selenium as selenomethionine
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
placebo tablet
Intervention Type
Dietary Supplement
Intervention Name(s)
selenium
Intervention Description
200 µg selenium as selenate
Intervention Type
Dietary Supplement
Intervention Name(s)
selenium
Intervention Description
400 µg selenium as selenate
Intervention Type
Dietary Supplement
Intervention Name(s)
selenium
Intervention Description
200 µg selenium as selenomethionine
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
placebo tablet
Primary Outcome Measure Information:
Title
Plasma selenium biomarkers
Time Frame
4 and 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adults with cirrhosis
Exclusion Criteria:
Pregnancy or planning a pregnancy
Selenium supplements of 25 µg or more within the past year
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond F Burk, M.D.
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
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Selenium Supplementation of Patients With Cirrhosis
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