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Sponsors and Collaborators: |
University of North Carolina National Center for Complementary and Alternative Medicine (NCCAM) |
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Information provided by: | The University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT00631085 |
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 |
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Healthy |
Drug: gamma tocopherol |
Phase I |
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 |
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 |
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1 |
Drug: gamma tocopherol
Maxi Gamma softgels 1200mg QD
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Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Martha Almond | 919-966-0759 | marrt@med.unc.edu |
United States, North Carolina | |
University of North Carolina CEMALB | Recruiting |
Chapel Hill, North Carolina, United States, 27599 | |
Principal Investigator: Michelle Hernandez, MD |
Principal Investigator: | Michelle Hernandez, MD | University of North Carolina |
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 |
healthy nonsmoking nonasthmatic volunteers |
Tocopherols Tocopherol acetate Vitamin E |
Healthy Gamma-Tocopherol Alpha-Tocopherol |
Antioxidants Molecular Mechanisms of Pharmacological Action Growth Substances Vitamins |
Physiological Effects of Drugs Micronutrients Protective Agents Pharmacologic Actions |