NCT00212212

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
6 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 years

First QC Date

September 19, 2005

Last Update Submit

March 6, 2012

Conditions

Cirrhosis

Keywords

selenium supplementsselenateselenomethioninebiomarkersplasma selenium concentrationplasma glutathione peroxidaseselenoprotein P

Outcome Measures

Primary Outcomes (1)

  • Plasma selenium biomarkers

    4 and 8 weeks

Study Arms (4)

1

EXPERIMENTAL

200 µg selenium as selenate

Dietary Supplement: selenium

2

EXPERIMENTAL

400 µg selenium as selenate

Dietary Supplement: selenium

3

EXPERIMENTAL

200 µg selenium as selenomethionine

Dietary Supplement: selenium

4

PLACEBO COMPARATOR

placebo tablet

Dietary Supplement: placebo

Interventions

seleniumDIETARY_SUPPLEMENT

200 µg selenium as selenate

1
placeboDIETARY_SUPPLEMENT

placebo tablet

4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults with cirrhosis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Fibrosis

Interventions

Selenium

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsMinerals

Study Officials

  • Raymond F Burk, M.D.

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 19, 2005

First Posted

September 21, 2005

Study Start

March 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)