Evaluation of a Short Course of Gamma Tocopherol Supplementation in Adult Subjects (Gammadose)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02610829 |
Recruitment Status :
Completed
First Posted : November 20, 2015
Last Update Posted : April 27, 2018
|
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | November 6, 2015 | |||
First Posted Date ICMJE | November 20, 2015 | |||
Last Update Posted Date | April 27, 2018 | |||
Actual Study Start Date ICMJE | November 2015 | |||
Actual Primary Completion Date | February 2016 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Change in gamma tocopherol serum levels [ Time Frame: Baseline, 30 hours after initial dosing ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
|
|||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Evaluation of a Short Course of Gamma Tocopherol Supplementation in Adult Subjects | |||
Official Title ICMJE | Evaluation of a Short Course of Gamma Tocopherol Supplementation in Adult Subjects | |||
Brief Summary | To evaluate serum levels of gamma tocopherol and it's metabolites after 3 doses, each separated by 12 hours. | |||
Detailed Description | 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 ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
|||
Condition ICMJE | Gamma Tocopherol Serum Levels | |||
Intervention ICMJE | Dietary Supplement: Gamma tocopherol
3 doses of 1400 mg gamma tocopherol (2 capsules, each is 700mg), at 12 hour intervals
Other Name: Vitamin E
|
|||
Study Arms ICMJE | Experimental: Gamma Tocopherol
Subjects will ingest 1400 mg gamma tocopherol, orally administered in 3 doses separated by 12 hours.
Intervention: Dietary Supplement: Gamma tocopherol
|
|||
Publications * | Wiser J, Alexis NE, Jiang Q, Wu W, Robinette C, Roubey R, Peden DB. In vivo gamma-tocopherol supplementation decreases systemic oxidative stress and cytokine responses of human monocytes in normal and asthmatic subjects. Free Radic Biol Med. 2008 Jul 1;45(1):40-9. doi: 10.1016/j.freeradbiomed.2008.03.002. Epub 2008 Mar 12. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
10 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | February 2016 | |||
Actual Primary Completion Date | February 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender ICMJE |
|
|||
Ages ICMJE | 18 Years to 50 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02610829 | |||
Other Study ID Numbers ICMJE | 15-1291 5R01ES023349-03 ( U.S. NIH Grant/Contract ) |
|||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | University of North Carolina, Chapel Hill | |||
Study Sponsor ICMJE | University of North Carolina, Chapel Hill | |||
Collaborators ICMJE | National Institute of Environmental Health Sciences (NIEHS) | |||
Investigators ICMJE |
|
|||
PRS Account | University of North Carolina, Chapel Hill | |||
Verification Date | April 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |