We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vitamin A and Response to Endotoxin

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2013 by Bandim Health Project.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00168649
First Posted: September 15, 2005
Last Update Posted: November 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Uppsala University Hospital
Institute for Human Nutrition, Royal Veterinary School, Copenhagen, Denmark
Information provided by:
Bandim Health Project
  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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: The Effect of Vitamin A on the Response to Endotoxin

Resource links provided by NLM:


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: June 2014
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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:

  Contacts and Locations
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
  More Information

ClinicalTrials.gov Identifier: NCT00168649     History of Changes
Other Study ID Numbers: 9583-2625-VITA-LPS
9583-2625
First Submitted: September 12, 2005
First Posted: September 15, 2005
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