Selenium Supplementation of Patients With Cirrhosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Vanderbilt University
- Enrollment
- 99
- Locations
- 1
- Primary Endpoint
- Plasma selenoprotein P, Plasma GPX-3 activity, Total plasma selenium
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •liver disease
- •aged 18 or above
Exclusion Criteria
- •substance abuse
- •renal failure
Arms & Interventions
1
200 µg selenium as selenate
Intervention: 200 µg selenium as selenate (Dietary Supplement)
2
400 µg selenium as selenate
Intervention: 400 µg selenium as selenate (Dietary Supplement)
3
200 µg selenium as selenomethionine
Intervention: 200 µg selenium as selenomethionine (Dietary Supplement)
4
placebo
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Plasma selenoprotein P, Plasma GPX-3 activity, Total plasma selenium
Time Frame: 8 week
Secondary Outcomes
No secondary outcomes reported
Investigators
RBurk
M.D.
Vanderbilt University