Viewing Study NCT00168649



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Last Modification Date: 2024-10-26 @ 9:15 AM
Study NCT ID: NCT00168649
Status: UNKNOWN
Last Update Posted: 2013-11-15
First Post: 2005-09-12

Brief Title: Vitamin A and Response to Endotoxin
Sponsor: Bandim Health Project
Organization: Bandim Health Project

Study Overview

Official Title: The Effect of Vitamin A on the Response to Endotoxin
Status: UNKNOWN
Status Verified Date: 2013-11
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Vitamin A given as treatment and pre-treatment has reduced the severity of symptoms after infusion with endotoxin in several animal models We intend to examine the effect of vitamin A as pre-treatment on the response to endotoxin in humans We furthermore wish to examine the long-term effects of vitamin A on the response to endotoxin We hypothesise that vitamin A decreases endotoxin levels and TNF-alfa responses
Detailed Description: Vitamin A given as treatment and pre-treatment has reduced the severity of symptoms after infusion with endotoxin in several animal models We intend to examine the effect of vitamin A as pre-treatment on the response to endotoxin in humans As studies in children in low-income countries have indicated that vitamin A has long-term effects on the immune system we furthermore wish to examine the long-term effects of vitamin A on the response to endotoxin This will be done in an established model using infusion with endotoxin to male human volunteers We hypothesise that vitamin A decreases endotoxin levels and TNF-alfa responses Furthermore we hypothesise that it reduces oxidative stress and injury

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
9583-2625 None None None