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Selenium Supplementation of Patients With Cirrhosis

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ClinicalTrials.gov Identifier: NCT00212212
Recruitment Status : Terminated (Insufficient funds to complete study.)
First Posted : September 21, 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:
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 or disease Intervention/treatment Phase
Cirrhosis Dietary Supplement: selenium Dietary Supplement: placebo Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Official Title: Human Selenium Nutritional Requirement and Biomarkers in Health and Disease
Study Start Date : March 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: 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




Primary Outcome Measures :
  1. Plasma selenium biomarkers [ Time Frame: 4 and 8 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): NCT00212212


Locations
United States, Tennessee
Vanderbilt University
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

Responsible Party: RBurk, M.D., Vanderbilt University
ClinicalTrials.gov Identifier: NCT00212212     History of Changes
Other Study ID Numbers: DK58763
R01DK058763 ( U.S. NIH Grant/Contract )
R01DK058763-06 ( U.S. NIH Grant/Contract )
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: March 7, 2012
Last Verified: March 2012

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

Additional relevant MeSH terms:
Selenium
Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Selenic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Growth Substances