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Selenium Supplementation of Patients With Cirrhosis

Human Selenium Nutritional Requirement and Biomarkers in Health and Disease

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00212212
Enrollment
99
Registered
2005-09-21
Start date
2006-03-31
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

Cirrhosis

Keywords

selenium supplements, selenate, selenomethionine, biomarkers, plasma selenium concentration, plasma glutathione peroxidase, selenoprotein P

Brief summary

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

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.

Interventions

DIETARY_SUPPLEMENTselenium

200 µg selenium as selenate

DIETARY_SUPPLEMENTplacebo

placebo tablet

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
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

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

Inclusion criteria

* adults with cirrhosis

Exclusion criteria

* Pregnancy or planning a pregnancy * Selenium supplements of 25 µg or more within the past year

Design outcomes

Primary

MeasureTime frame
Plasma selenium biomarkers4 and 8 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026