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Selenium Supplementation of Patients With Cirrhosis

Selenium Supplementation of Patients With Cirrhosis

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00271245
Enrollment
99
Registered
2005-12-30
Start date
2006-02-28
Completion date
2012-03-31
Last updated
2012-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Disease

Keywords

cirrhosis, liver disease, selenium, selenoproteins, selenoprotein P, biomarkers

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.

Interventions

DIETARY_SUPPLEMENT200 µg selenium as selenate

200 µg selenium as selenate

DIETARY_SUPPLEMENT400 µg selenium as selenate

400 µg selenium as selenate

DIETARY_SUPPLEMENT200 µg selenium as selenomethionine

200 µg selenium as selenomethionine

DIETARY_SUPPLEMENTPlacebo

Placebo

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Vanderbilt University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* liver disease * aged 18 or above

Exclusion criteria

* substance abuse * renal failure

Design outcomes

Primary

MeasureTime frame
Plasma selenoprotein P, Plasma GPX-3 activity, Total plasma selenium8 week

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026