Selenium Supplementation of Patients With Cirrhosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Human Selenium Nutritional Requirement and Biomarkers in Health and Disease

Conditions
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Cirrhosis

Intervention / Treatment
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* Dietary Supplement: selenium
* Dietary Supplement: selenium
* Dietary Supplement: selenium
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults with cirrhosis Exclusion Criteria: Pregnancy or planning a pregnancy Selenium supplements of 25 µg or more within the past year

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>200 µg selenium as selenate | Dietary Supplement: selenium<br>* 200 µg selenium as selenate<br>|
| Experimental: 2<br>400 µg selenium as selenate | Dietary Supplement: selenium<br>* 400 µg selenium as selenate<br>|
| Experimental: 3<br>200 µg selenium as selenomethionine | Dietary Supplement: selenium<br>* 200 µg selenium as selenomethionine<br>|
| Placebo Comparator: 4<br>placebo tablet | Dietary Supplement: placebo<br>* placebo tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma selenium biomarkers |  | 4 and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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selenium supplements, selenate, selenomethionine, biomarkers, plasma selenium concentration, plasma glutathione peroxidase, selenoprotein P