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Vitamin A and Response to Endotoxin

The Effect of Vitamin A on the Response to Endotoxin

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00168649
Enrollment
40
Registered
2005-09-15
Start date
2005-06-30
Completion date
2014-06-30
Last updated
2013-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endotoxin Levels, TNF-alfa

Keywords

Vitamin A, Endotoxin, TNF-alfa

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.

Interventions

DRUGVitamin A

Sponsors

Uppsala University Hospital
CollaboratorOTHER
Institute for Human Nutrition, Royal Veterinary School, Copenhagen, Denmark
CollaboratorUNKNOWN
Bandim Health Project
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE

Eligibility

Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Endotoxin levels
TNF-alfa levels

Secondary

MeasureTime frame
Measures of oxidative injury and stress
Retinol and beta-caroten levels
Haematological values
Clinical markers

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026