Effect of Gamma Tocopherol Supplementation on Neutrophil Response to 20,000 EU of Clinical Center Reference Endotoxin in Normal Adults (GammaTox)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Effect of Gamma Tocopherol Supplementation on Neutrophil Response to 20,000 EU of Clinical Center Reference Endotoxin in Normal Adults |
- 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 ]
| Enrollment: | 18 |
| Study Start Date: | May 2008 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2009 (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 |
Inclusion Criteria:
- Healthy nonsmoking volunteers with normal lung function
Exclusion Criteria:
- Chronic illness
- Asthma
- Active allergies
Contacts and Locations| United States, North Carolina | |
| University of North Carolina CEMALB | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Principal Investigator: | Michelle Hernandez, MD | University of North Carolina |
More Information
No publications provided
| Responsible Party: | Michelle Hernandez, MD, UNC_Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT00631085 History of Changes |
| Other Study ID Numbers: | GCRC 2678 IRB 08-0082, 5P01AT002620 |
| Study First Received: | February 28, 2008 |
| Last Updated: | April 14, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of North Carolina, Chapel Hill:
|
healthy nonsmoking nonasthmatic volunteers |
Additional relevant MeSH terms:
|
Gamma-Tocopherol Tocopherols Vitamin E Tocotrienols Antioxidants Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Protective Agents Physiological Effects of Drugs Vitamins Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on June 17, 2013