Evaluation of a Short Course of Gamma Tocopherol Supplementation in Adult Subjects (Gammadose)
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|ClinicalTrials.gov Identifier: NCT02610829|
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : April 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Gamma Tocopherol Serum Levels||Dietary Supplement: Gamma tocopherol||Not Applicable|
In previous studies the investigators have demonstrated that gamma-tocopherol-enriched (yT) supplementation decreased systemic oxidative stress, increased serum levels of yT, and inhibited monocyte responses to LPS without any adverse health effects. Free Radic Biol Med. 2008 Jul 1;45(1):40-9. doi: 10.1016/j.freeradbiomed.2008.03.002. Epub 2008 Mar 12.
Oxidant stress plays an important role in mucosal inflammation. Oxidant stress occurs individuals after exposure to air pollution, including high levels of ozone, LPS exposure and woodsmoke particle exposure. Potential exposure to all of these are naturally occurring events. Previous studies have also shown that asthmatic individuals tend to have lower endogenous levels of antioxidants such a s vitamins E and C, and that supplementing antioxidants can decrease exacerbation's associated with ozone exposure in children. The investigators are interested in future studies to examine the benefits of a rapid gamma tocopherol supplement in individuals who will be exposed to air pollution, either in a controlled chamber study or in a real life event, such as during high O3 days or when a woodsmoke fire is in their neighborhood.
This study is to address the question: can the investigators see an increase in serum levels of gT with a shorter course of gT supplementation? Additionally, before embarking on other investigations of gT as a potential prophylactic supplement, it is prudent to determine is discernible levels can be achieved with a shorter dose of gT.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Evaluation of a Short Course of Gamma Tocopherol Supplementation in Adult Subjects|
|Actual Study Start Date :||November 2015|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||February 2016|
Experimental: Gamma Tocopherol
Subjects will ingest 1400 mg gamma tocopherol, orally administered in 3 doses separated by 12 hours.
Dietary Supplement: Gamma tocopherol
3 doses of 1400 mg gamma tocopherol (2 capsules, each is 700mg), at 12 hour intervals
Other Name: Vitamin E
- Change in gamma tocopherol serum levels [ Time Frame: Baseline, 30 hours after initial dosing ]
- Change in gamma-CEHC [ Time Frame: Baseline, 30 hours after dosing initial dosing ]
- Change in 5-NO-gamma tocopherol [ Time Frame: Baseline, 30 hours after dosing initial dosing ]
- Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment [ Time Frame: Baseline, 30 hours after initial dosing ]
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): NCT02610829
|United States, North Carolina|
|Center for Environmental Medicine, Asthma and Lung Biology|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||David B. Peden, MD, MS||University of North Carolina, Chapel Hill|