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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started Feb 2006

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.1 years study duration

First Submitted

Initial submission to the registry

December 29, 2005

Completed

1 day until next milestone

First Posted

Study publicly available on registry

December 30, 2005

Completed

1 month until next milestone

Study Start

First participant enrolled

February 1, 2006

Completed

6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed

Last Updated

March 7, 2012

Status Verified

March 1, 2012

Enrollment Period

6.1 years

First QC Date

December 29, 2005

Last Update Submit

March 6, 2012

Conditions

Liver Disease

Keywords

cirrhosisliver diseaseseleniumselenoproteinsselenoprotein Pbiomarkers

Outcome Measures

Primary Outcomes (1)

Plasma selenoprotein P, Plasma GPX-3 activity, Total plasma selenium
8 week

Study Arms (4)

1

EXPERIMENTAL

200 µg selenium as selenate

Dietary Supplement: 200 µg selenium as selenate

2

EXPERIMENTAL

400 µg selenium as selenate

Dietary Supplement: 400 µg selenium as selenate

3

EXPERIMENTAL

200 µg selenium as selenomethionine

Dietary Supplement: 200 µg selenium as selenomethionine

4

PLACEBO COMPARATOR

placebo

Dietary Supplement: Placebo

Interventions

200 µg selenium as selenateDIETARY_SUPPLEMENT

200 µg selenium as selenate

400 µg selenium as selenateDIETARY_SUPPLEMENT

400 µg selenium as selenate

200 µg selenium as selenomethionineDIETARY_SUPPLEMENT

200 µg selenium as selenomethionine

PlaceboDIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

liver disease
aged 18 or above

You may not qualify if:

substance abuse
renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Vanderbilt Universitylead
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

Burk RF, Hill KE, Motley AK, Byrne DW, Norsworthy BK. Selenium deficiency occurs in some patients with moderate-to-severe cirrhosis and can be corrected by administration of selenate but not selenomethionine: a randomized controlled trial. Am J Clin Nutr. 2015 Nov;102(5):1126-33. doi: 10.3945/ajcn.115.110932. Epub 2015 Oct 14.
PMID: 26468123DERIVED

MeSH Terms

Conditions

Liver DiseasesFibrosis

Interventions

SeleniumSelenic AcidSelenomethionine

Condition Hierarchy (Ancestors)

Digestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsMineralsSelenium CompoundsOrganoselenium CompoundsOrganic ChemicalsMethionineAmino Acids, SulfurSulfur CompoundsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

Raymond F Burk, M.D.
Vanderbilt University
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: M.D.

Study Record Dates

First Submitted

December 29, 2005

First Posted

December 30, 2005

Study Start

February 1, 2006

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

March 7, 2012

Record last verified: 2012-03

Locations

US(1)

Study Stopped

Selenium Supplementation of Patients With Cirrhosis

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (4)

1

2

3

4

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (4)

1

2

3

4

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations