Vitamin A and Response to Endotoxin

Condition(s) targeted: TNF-Alfa; Endotoxin Levels

Intervention: Vitamin A (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Bandim Health Project

Official(s) and/or principal investigator(s):
Bente K Pedersen, MD, DMSc, Study Director, Affiliation: Rigshospitalet, Denmark

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.

Official title: The Effect of Vitamin A on the Response to Endotoxin

Study design: Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Primary outcome:

Endotoxin levels

TNF-alfa levels

Secondary outcome:

Measures of oxidative injury and stress

Retinol and beta-caroten levels

Haematological values

Clinical markers

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.

Minimum age: 18 Years. Maximum age: 35 Years. Gender(s): Male.

Criteria:

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

Rigshospitalet, Department M7641, Copenhagen 2100, Denmark

Starting date: June 2005
Ending date: December 2005
Last updated: October 18, 2006