Effect of Gamma Tocopherol Enriched Supplementation on Response to Inhaled O3 Exposure (Gammoz)
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|ClinicalTrials.gov Identifier: NCT02911688|
Recruitment Status : Completed
First Posted : September 22, 2016
Last Update Posted : February 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Allergic Asthma||Drug: gamma tocopherol Drug: Placebo||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effect of Gamma Tocopherol Enriched Supplementation on Response to Inhaled O3 Exposure|
|Study Start Date :||September 2016|
|Actual Primary Completion Date :||February 13, 2019|
|Actual Study Completion Date :||February 13, 2019|
Placebo Comparator: placebo
Safflower oil, taken in 2 capsules every 12 hours for a total of 4 doses
The effect of supplemental with gamma tocopherol on O3 response will be assessed using the difference pre and after placebo dosing.
Other Name: Safflower oil
Active Comparator: gamma tocopherol
gamma tocopherol 1400 mg, taken as 2 700 mg capsules every 12 hours for a total of 4 doses
Drug: gamma tocopherol
The effect of supplemental with gamma tocopherol on O3 response will be assessed using the difference pre and after γT dosing.
Other Name: Vitamin E
- change in sputum %PMNs [ Time Frame: 8 hours after final dose of study drug ]After supplementation with either active or placebo, subjects will undergo O3 exposure.
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): NCT02911688
|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||UNC|