Vitamin A and Response to Endotoxin
November 14, 2013 updated by: Bandim Health Project
The Effect of Vitamin A on the Response to Endotoxin
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.
Study Overview
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 Type
Interventional
Enrollment
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Copenhagen, Denmark, 2100
- Rigshospitalet, Department M7641
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria: Healthy, male, between 18 and 35 years of age, non-smoker, no medicine, no infections in preceding 14 days
Exclusion Criteria:
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
Endotoxin levels
|
|
TNF-alfa levels
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
Measures of oxidative injury and stress
|
|
Retinol and beta-caroten levels
|
|
Haematological values
|
|
Clinical markers
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Bente K Pedersen, MD, DMSc, Rigshospitalet, Denmark
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2005
Study Completion
June 1, 2014
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Estimate)
November 15, 2013
Last Update Submitted That Met QC Criteria
November 14, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9583-2625-VITA-LPS
- 9583-2625
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.