Suspended

Human Selenium Nutritional Requirement and Biomarkers in Health and Disease

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What is being tested

selenium

+ placebo

Dietary Supplement
Who is being recruted

Fibrosis

+ Pathologic Processes

+ Pathological Conditions, Signs and Symptoms

Over 18 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Placebo-Controlled
Interventional
Study Start: March 2006
See protocol details

Summary

Principal SponsorVanderbilt University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2006

Actual date on which the first participant was enrolled.

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 TitleHuman Selenium Nutritional Requirement and Biomarkers in Health and Disease
NCT00212212
Principal SponsorVanderbilt University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

99 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Criteria

1 inclusion criteria required to participate
adults with cirrhosis

2 exclusion criteria prevent from participating
Pregnancy or planning a pregnancy

Selenium supplements of 25 µg or more within the past year

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
200 µg selenium as selenate

Group II

Experimental
400 µg selenium as selenate

Group III

Experimental
200 µg selenium as selenomethionine

Group IV

Placebo
placebo tablet

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Vanderbilt University

Nashville, United StatesOpen Vanderbilt University in Google Maps
SuspendedOne Study Center