The Effect of Vitamin A on the Response to Endotoxin
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Bandim Health Project
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- TNF-alfa levels
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
TNF-alfa levels
Endotoxin levels
Secondary Outcomes
- Measures of oxidative injury and stress
- Haematological values
- Clinical markers
- Retinol and beta-caroten levels