Vitamin A and Response to Endotoxin

Endotoxin Levels Clinical Trial

Official title:

The Effect of Vitamin A on the Response to Endotoxin

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00168649
• Other study ID #: 9583-2625-VITA-LPS
• Secondary ID: 9583-2625
• Status: Active, not recruiting
• Phase: N/A
• First received: September 12, 2005
• Last updated: November 14, 2013
• Start date: June 2005
• Est. completion date: June 2014

Study information

• Verified date: November 2013
• Source: Bandim Health Project
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Endotoxin Levels
• TNF-alfa

Intervention

Drug:
• Vitamin A

Locations

Country	Name	City	State
Denmark	Rigshospitalet, Department M7641	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
Bandim Health Project	Institute for Human Nutrition, Royal Veterinary School, Copenhagen, Denmark, Uppsala University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endotoxin levels
Primary	TNF-alfa levels
Secondary	Measures of oxidative injury and stress
Secondary	Retinol and beta-caroten levels
Secondary	Haematological values
Secondary	Clinical markers