Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00271245
Other study ID # DK58763-c
Secondary ID R01DK058763DK587
Status Terminated
Phase N/A
First received December 29, 2005
Last updated March 6, 2012
Start date February 2006
Est. completion date March 2012

Study information

Verified date March 2012
Source Vanderbilt University
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether patients with liver cirrhosis can improve their selenium nutritional status by taking supplemental selenium.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 99
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- liver disease

- aged 18 or above

Exclusion Criteria:

- substance abuse

- renal failure

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
200 µg selenium as selenate
200 µg selenium as selenate
400 µg selenium as selenate
400 µg selenium as selenate
200 µg selenium as selenomethionine
200 µg selenium as selenomethionine
Placebo
Placebo

Locations

Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (2)

Lead Sponsor Collaborator
Vanderbilt University National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plasma selenoprotein P, Plasma GPX-3 activity, Total plasma selenium 8 week No
See also
  Status Clinical Trial Phase
Completed NCT02798861 - Controlled Attenuation Parameter (CAP) in Liver Allografts
Completed NCT01968395 - Pharmacokinetics of Caspofungin After One Dose in Patients With Liver Failure Phase 4
Completed NCT01437969 - Pharmacogenomics Study on IL28B Genetic Variants in Italian Patients With HCV Infection naïve to Treatment.
Recruiting NCT00155376 - Intravenous-Morphine and Glucagon-Usage Enhanced MR Cholangiography Phase 4
Recruiting NCT00172705 - Quantitative Diagnosis of Fatty Liver by Dual Energy CT Technique N/A
Completed NCT04185454 - Estimation of Minimum Efficacy Daily Dose of Jarlsberg Cheese N/A
Completed NCT02506335 - Liver Function Measured by HepQuant-SHUNT in the Prediction of Outcomes in Patients With Heart Disease Early Phase 1
Completed NCT02520609 - Dynamic Post-Prandial Metabolism in Patients With Non-Alcoholic Fatty Liver Disease
Completed NCT02306018 - Evaluation of a New Calibrated Pulse Wave Analysis Method(EV1000™/volumeView™) for Cardiac Output Monitoring in Adult Liver Transplantation N/A
Completed NCT01988753 - Non-invasive Biomarkers of Fibrosis in Pediatric Liver Diseases
Completed NCT01970904 - Pharmacokinetics, Pharmacodynamics and Safety of DEB025 Plus Ribavirin in Chronic Hepatitis C Genotype 2 and 3 Treatment naïve Patients N/A
Terminated NCT00741117 - Conjugated Hyperbilirubinemia and Pulse Oximetry N/A
Enrolling by invitation NCT01483248 - Human Menstrual Blood-derived Mesenchymal Stem Cells for Patients With Liver Cirrhosis Phase 1/Phase 2
Completed NCT00074386 - Kidney and Liver Transplantation in People With HIV N/A
Completed NCT00245830 - Ischemic Preconditioning of Liver in Cadaver Donors N/A
Completed NCT02329821 - Change of Lactate Concentration During Hartmann Solution Infusion for Hepatic Resection N/A
Completed NCT01650181 - Effects of Siliphos-Selenium-Methionine-Alpha Lipoic Acid in Patients With Fatty Liver and Non-alcoholic Steatohepatitis Phase 4
Completed NCT01303549 - Anidulafungin vs Amphotericin B Safety in High Risk Hepatic Transplant Recipients Phase 4
Completed NCT00799851 - A Randomized Controlled Trial Comparing Band Ligation and Cyanoacrylate Injection for Esophageal Varices Phase 4
Completed NCT00058890 - Gabapentin to Treat Itch in Patients With Liver Disease Phase 3