MedPath

Vitamin A and Response to Endotoxin

Not Applicable
Conditions
TNF-alfa
Endotoxin Levels
Registration Number
NCT00168649
Lead Sponsor
Bandim Health Project
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
Male
Target Recruitment
40
Inclusion Criteria

Healthy, male, between 18 and 35 years of age, non-smoker, no medicine, no infections in preceding 14 days

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
TNF-alfa levels
Endotoxin levels
Secondary Outcome Measures
NameTimeMethod
Haematological values
Clinical markers
Retinol and beta-caroten levels
Measures of oxidative injury and stress

Trial Locations

Locations (1)

Rigshospitalet, Department M7641

🇩🇰

Copenhagen, Denmark

© Copyright 2025. All Rights Reserved by MedPath