Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00212212
Status:
TERMINATED
Last Update Posted:
2012-03-07
First Post:
2005-09-19
Brief Title:
Selenium Supplementation of Patients With Cirrhosis
Sponsor:
Vanderbilt University
Organization:
Vanderbilt University
Study Overview
Official Title:
Human Selenium Nutritional Requirement and Biomarkers in Health and Disease
Status:
TERMINATED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient funds to complete study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DK058763-06 | NIH | None | httpsreporternihgovquickSearchR01DK058763-06 |
| R01DK058763 | NIH | None | None |