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Effect of Gamma Tocopherol Supplementation on Neutrophil Response to 20,000 EU of Clinical Center Reference Endotoxin in Normal Adults (GammaTox)
This study is currently recruiting participants.
Verified by The University of North Carolina, Chapel Hill, August 2008
Sponsors and Collaborators: University of North Carolina
National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: The University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00631085
  Purpose

The purpose of this research study is to learn whether high dose vitamin E (gamma tocopherol) will affect the way your body responds to an acute inflammation in your lungs. Vitamin E is found in soybean and vegetable oils as well as many plant seeds. Gamma tocopherol (gT), a component of vitamin E, composes 70-80% of Vitamin E in the U.S. diet. Alpha tocopherol (aT), another large component of vitamin E, makes up less than 10% of vitamin E in the U.S. diet, but is the major form in blood and tissue. It is also the major form of Vitamin E in over-the-counter supplements. However, gT has anti-inflammatory properties which are not present in aT. Preliminary data suggests that gT protects from ozone-induced exacerbation in animal studies, and previous studies have shown levels of gT are inversely associated with heart disease.

We will ask you to undergo a challenge with endotoxin, which is a bacterial component of air pollution. From other studies we have done, we know that if you inhale 20,000 EUs (endotoxin units) we will see an increase in the number of neutrophils (a type of white blood cell that your body produces to fight infection) in your lung cells without causing you to have flu-like symptoms. We will investigate if there is a change in your lung inflammatory cells after the endotoxin challenge when you take the gT versus when you take a placebo.


Condition Intervention Phase
Healthy
Drug: gamma tocopherol
Phase I

Drug Information available for: Vitamin E alpha-Tocopherol alpha-Tocopheryl acetate Tocopherols
U.S. FDA Resources
Study Type: Interventional
Study Design: Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Safety/Efficacy Study
Official Title: Effect of Gamma Tocopherol Supplementation on Neutrophil Response to 20,000 EU of Clinical Center Reference Endotoxin in Normal Adults

Further study details as provided by The University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • The primary goal of this study is to determine the effect of γT on endotoxin-induced airway inflammation in non-allergic, non-asthmatic subjects. [ Time Frame: CCRE challenge after 7 days of treatment with gT or SO ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: May 2008
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Drug: gamma tocopherol
Maxi Gamma softgels 1200mg QD

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy nonsmoking volunteers with normal lung function

Exclusion Criteria:

  • Chronic illness
  • Asthma
  • Active allergies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00631085

Contacts
Contact: Martha Almond 919-966-0759 marrt@med.unc.edu

Locations
United States, North Carolina
University of North Carolina CEMALB Recruiting
Chapel Hill, North Carolina, United States, 27599
Principal Investigator: Michelle Hernandez, MD            
Sponsors and Collaborators
University of North Carolina
Investigators
Principal Investigator: Michelle Hernandez, MD University of North Carolina
  More Information

Responsible Party: UNC_Chapel Hill ( Michelle Hernandez, MD )
Study ID Numbers: GCRC 2678 IRB 08-0082
Study First Received: February 28, 2008
Last Updated: August 26, 2008
ClinicalTrials.gov Identifier: NCT00631085  
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of North Carolina, Chapel Hill:
healthy nonsmoking nonasthmatic volunteers

Study placed in the following topic categories:
Tocopherols
Tocopherol acetate
Vitamin E
Healthy
Gamma-Tocopherol
Alpha-Tocopherol

Additional relevant MeSH terms:
Antioxidants
Molecular Mechanisms of Pharmacological Action
Growth Substances
Vitamins
Physiological Effects of Drugs
Micronutrients
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009