Vitamin A and Response to Endotoxin

This study is ongoing, but not recruiting participants.

First Received: September 12, 2005 Last Updated: February 18, 2008 History of Changes

Sponsor:	Bandim Health Project
Collaborators:	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

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

Resource links provided by NLM:

Drug Information available for: Retinol Vitamin A

U.S. FDA Resources

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

No publications provided

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

Keywords provided by Bandim Health Project:

Vitamin A
Endotoxin
TNF-alfa

Additional relevant MeSH terms:

Anticarcinogenic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Protective Agents

Pharmacologic Actions
Retinol palmitate
Vitamin A
Vitamins
Therapeutic Uses
Micronutrients

ClinicalTrials.gov processed this record on November 09, 2009