Vitamin A and Response to Endotoxin - Full Text View

Sponsors and Collaborators:	Bandim Health Project Uppsala University Hospital Institute for Human Nutrition, Royal Veterinary School, Copenhagen, Denmark
Information provided by:	Bandim Health Project
ClinicalTrials.gov Identifier:	NCT00168649

Purpose

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	Intervention
TNF-Alfa Endotoxin Levels	Drug: Vitamin A

Drug Information available for: Vitamin A Retinol Tumor Necrosis Factors

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	The Effect of Vitamin A on the Response to Endotoxin

Further study details as provided by Bandim Health Project:

Primary Outcome Measures:

Endotoxin levels
TNF-alfa levels

Secondary Outcome Measures:

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

Estimated Enrollment:	40
Study Start Date:	June 2005
Estimated Study Completion Date:	December 2005

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.

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders 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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

Study ID Numbers:	9583-2625-VITA-LPS, 9583-2625
Study First Received:	September 12, 2005
Last Updated:	February 18, 2008
ClinicalTrials.gov Identifier:	NCT00168649
Health Authority:	Denmark: Ethics Committee

Keywords provided by Bandim Health Project:

Vitamin A
Endotoxin
TNF-alfa

Study placed in the following topic categories:

Retinol palmitate
Vitamin A

Additional relevant MeSH terms:

Anticarcinogenic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Growth Substances

Vitamins
Physiological Effects of Drugs
Micronutrients
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009