Selenium Supplementation of Patients With Cirrhosis

Vanderbilt University

Status: Terminated

Conditions: Liver Disease

Treatments: Dietary Supplement: 400 µg selenium as selenate; Dietary Supplement: 200 µg selenium as selenate; Dietary Supplement: Placebo; Dietary Supplement: 200 µg selenium as selenomethionine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00271245

DK58763-c

DK58763

R01DK058763 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to determine whether patients with liver cirrhosis can improve their selenium nutritional status by taking supplemental selenium.

Full 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.

Enrollment: 99 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• liver disease
• aged 18 or above

Exclusion criteria

• substance abuse
• renal failure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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99 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

200 µg selenium as selenate

Treatment:

Dietary Supplement: 200 µg selenium as selenate

2

Experimental group

Description:

400 µg selenium as selenate

Treatment:

Dietary Supplement: 400 µg selenium as selenate

3

Experimental group

Description:

200 µg selenium as selenomethionine

Treatment:

Dietary Supplement: 200 µg selenium as selenomethionine

4

Placebo Comparator group

Description:

placebo

Treatment:

Dietary Supplement: Placebo