Vitamin A and Response to Endotoxin

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Uppsala University Hospital
Institute for Human Nutrition, Royal Veterinary School, Copenhagen, Denmark
Information provided by:
Bandim Health Project
ClinicalTrials.gov Identifier:
NCT00168649
First received: September 12, 2005
Last updated: November 14, 2013
Last verified: November 2013
  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-Blind
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

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
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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

ClinicalTrials.gov Identifier: NCT00168649     History of Changes
Other Study ID Numbers: 9583-2625-VITA-LPS, 9583-2625
Study First Received: September 12, 2005
Last Updated: November 14, 2013
Health Authority: Denmark: Ethics Committee

Keywords provided by Bandim Health Project:
Vitamin A
Endotoxin
TNF-alfa

Additional relevant MeSH terms:
Vitamin A
Vitamins
Retinol palmitate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014