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Selenium Supplementation of Patients With Cirrhosis

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ClinicalTrials.gov Identifier: NCT00271245
Recruitment Status : Terminated (Insufficient funds to complete study.)
First Posted : December 30, 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

Tracking Information
First Submitted Date  ICMJE December 29, 2005
First Posted Date  ICMJE December 30, 2005
Last Update Posted Date March 7, 2012
Study Start Date  ICMJE February 2006
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2008)
Plasma selenoprotein P, Plasma GPX-3 activity, Total plasma selenium [ Time Frame: 8 week ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 29, 2005)
Plasma selenoprotein P, Plasma GPX-3 activity, Total plasma selenium
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Selenium Supplementation of Patients With Cirrhosis
Official Title  ICMJE Selenium Supplementation of Patients With Cirrhosis
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Liver Disease
Intervention  ICMJE
  • Dietary Supplement: 200 µg selenium as selenate
    200 µg selenium as selenate
  • Dietary Supplement: 400 µg selenium as selenate
    400 µg selenium as selenate
  • Dietary Supplement: 200 µg selenium as selenomethionine
    200 µg selenium as selenomethionine
  • Dietary Supplement: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: 1
    200 µg selenium as selenate
    Intervention: Dietary Supplement: 200 µg selenium as selenate
  • Experimental: 2
    400 µg selenium as selenate
    Intervention: Dietary Supplement: 400 µg selenium as selenate
  • Experimental: 3
    200 µg selenium as selenomethionine
    Intervention: Dietary Supplement: 200 µg selenium as selenomethionine
  • Placebo Comparator: 4
    placebo
    Intervention: Dietary Supplement: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 6, 2012)
99
Original Enrollment  ICMJE
 (submitted: December 29, 2005)
144
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • liver disease
  • aged 18 or above

Exclusion Criteria:

  • substance abuse
  • renal failure
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00271245
Other Study ID Numbers  ICMJE DK58763-c
R01DK058763 ( U.S. NIH Grant/Contract )
DK58763
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party RBurk, Vanderbilt University
Study Sponsor  ICMJE Vanderbilt University
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Raymond F Burk, M.D. Vanderbilt University
PRS Account Vanderbilt University
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP