Vitamin A and Response to Endotoxin - Tabular View

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

February 18, 2008

Start Date ^ICMJE

June 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Endotoxin levels
TNF-alfa levels

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00168649 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Vitamin A and Response to Endotoxin

Official Title ^ICMJE

The Effect of Vitamin A on the Response to Endotoxin

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Condition ^ICMJE

TNF-Alfa
Endotoxin Levels

Intervention ^ICMJE

Drug: Vitamin A

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

December 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Exclusion Criteria:

Gender

Male

Ages

18 Years to 35 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00168649

Responsible Party

Study ID Numbers ^ICMJE

9583-2625-VITA-LPS, 9583-2625

Study Sponsor ^ICMJE

Bandim Health Project

Collaborators ^ICMJE

Uppsala University Hospital
Institute for Human Nutrition, Royal Veterinary School, Copenhagen, Denmark

Investigators ^ICMJE

Study Director:

Bente K Pedersen, MD, DMSc

Rigshospitalet, Denmark

Information Provided By

Bandim Health Project

Verification Date

September 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP