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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Liver Disease | Dietary Supplement: 200 µg selenium as selenate Dietary Supplement: 400 µg selenium as selenate Dietary Supplement: 200 µg selenium as selenomethionine Dietary Supplement: Placebo | Not Applicable |
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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 99 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Selenium Supplementation of Patients With Cirrhosis |
Study Start Date : | February 2006 |
Actual Primary Completion Date : | March 2012 |
Actual Study Completion Date : | March 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
200 µg selenium as selenate
|
Dietary Supplement: 200 µg selenium as selenate
200 µg selenium as selenate |
Experimental: 2
400 µg selenium as selenate
|
Dietary Supplement: 400 µg selenium as selenate
400 µg selenium as selenate |
Experimental: 3
200 µg selenium as selenomethionine
|
Dietary Supplement: 200 µg selenium as selenomethionine
200 µg selenium as selenomethionine |
Placebo Comparator: 4
placebo
|
Dietary Supplement: Placebo
Placebo |
- Plasma selenoprotein P, Plasma GPX-3 activity, Total plasma selenium [ Time Frame: 8 week ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- liver disease
- aged 18 or above
Exclusion Criteria:
- substance abuse
- renal failure

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): NCT00271245
United States, Tennessee | |
Vanderbilt University Medical Center | |
Nashville, Tennessee, United States, 37232 |
Principal Investigator: | Raymond F Burk, M.D. | Vanderbilt University |
Responsible Party: | RBurk, M.D., Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00271245 |
Other Study ID Numbers: |
DK58763-c R01DK058763 ( U.S. NIH Grant/Contract ) DK58763 |
First Posted: | December 30, 2005 Key Record Dates |
Last Update Posted: | March 7, 2012 |
Last Verified: | March 2012 |
cirrhosis liver disease selenium |
selenoproteins selenoprotein P biomarkers |
Liver Diseases Fibrosis Pathologic Processes Digestive System Diseases Selenium Selenic Acid |
Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Trace Elements Micronutrients |