Selenium Supplementation of Patients With Cirrhosis
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cirrhosis |
Dietary Supplement: selenium Dietary Supplement: placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Diagnostic |
| Official Title: | Human Selenium Nutritional Requirement and Biomarkers in Health and Disease |
- Plasma selenium biomarkers [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 99 |
| Study Start Date: | March 2006 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
200 µg selenium as selenate
|
Dietary Supplement: selenium
200 µg selenium as selenate
|
|
Experimental: 2
400 µg selenium as selenate
|
Dietary Supplement: selenium
400 µg selenium as selenate
|
|
Experimental: 3
200 µg selenium as selenomethionine
|
Dietary Supplement: selenium
200 µg selenium as selenomethionine
|
|
Placebo Comparator: 4
placebo tablet
|
Dietary Supplement: placebo
placebo tablet
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| United States, Tennessee | |
| Vanderbilt University | |
| Nashville, Tennessee, United States, 37232 | |
| Principal Investigator: | Raymond F Burk, M.D. | Vanderbilt University |
More Information
No publications provided
| Responsible Party: | RBurk, M.D., Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00212212 History of Changes |
| Other Study ID Numbers: | DK58763, R01DK058763, RO1 DK58763-06 |
| Study First Received: | September 19, 2005 |
| Last Updated: | March 6, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Vanderbilt University:
|
selenium supplements selenate selenomethionine biomarkers |
plasma selenium concentration plasma glutathione peroxidase selenoprotein P |
Additional relevant MeSH terms:
|
Selenium Liver Cirrhosis Fibrosis Liver Diseases Digestive System Diseases Pathologic Processes Trace Elements |
Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |
ClinicalTrials.gov processed this record on May 16, 2013