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Vitamin A and Response to Endotoxin

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ClinicalTrials.gov Identifier: NCT00168649
Recruitment Status : Unknown
Verified November 2013 by Bandim Health Project.
Recruitment status was:  Active, not recruiting
First Posted : September 15, 2005
Last Update Posted : November 15, 2013
Sponsor:
Collaborators:
Uppsala University Hospital
Institute for Human Nutrition, Royal Veterinary School, Copenhagen, Denmark
Information provided by:
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.

Condition or disease Intervention/treatment Phase
TNF-alfa Endotoxin Levels Drug: Vitamin A Not Applicable

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  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: The Effect of Vitamin A on the Response to Endotoxin
Study Start Date : June 2005
Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin A
U.S. FDA Resources




Primary Outcome Measures :
  1. Endotoxin levels
  2. TNF-alfa levels

Secondary Outcome Measures :
  1. Measures of oxidative injury and stress
  2. Retinol and beta-caroten levels
  3. Haematological values
  4. Clinical markers


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00168649


Locations
Denmark
Rigshospitalet, Department M7641
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Bandim Health Project
Uppsala University Hospital
Institute for Human Nutrition, Royal Veterinary School, Copenhagen, Denmark
Investigators
Study Director: Bente K Pedersen, MD, DMSc Rigshospitalet, Denmark

ClinicalTrials.gov Identifier: NCT00168649     History of Changes
Other Study ID Numbers: 9583-2625-VITA-LPS
9583-2625
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: November 15, 2013
Last Verified: November 2013

Keywords provided by Bandim Health Project:
Vitamin A
Endotoxin
TNF-alfa

Additional relevant MeSH terms:
Vitamins
Vitamin A
Retinol palmitate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents