Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00271245
Status:
TERMINATED
Last Update Posted:
2012-03-07
First Post:
2005-12-29
Brief Title:
Selenium Supplementation of Patients With Cirrhosis
Sponsor:
Vanderbilt University
Organization:
Vanderbilt University
Study Overview
Official Title:
Selenium Supplementation of Patients With Cirrhosis
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:
The purpose of this study is to determine whether patients with liver cirrhosis can improve their selenium nutritional status by taking supplemental selenium
Detailed 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
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
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 |
|---|---|---|---|
| DK58763 | US NIH GrantContract | None | httpsreporternihgovquickSearchR01DK058763 |
| R01DK058763 | NIH | None | None |