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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
Sponsor:
Collaborator:
National Institute of Environmental Health Sciences (NIEHS)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
To evaluate serum levels of gamma tocopherol and it's metabolites after 3 doses, each separated by 12 hours.

Condition or disease Intervention/treatment Phase
Gamma Tocopherol Serum Levels Dietary Supplement: Gamma tocopherol Not Applicable

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.


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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


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Change in gamma tocopherol serum levels [ Time Frame: Baseline, 30 hours after initial dosing ]

Secondary Outcome Measures :
  1. Change in gamma-CEHC [ Time Frame: Baseline, 30 hours after dosing initial dosing ]
  2. Change in 5-NO-gamma tocopherol [ Time Frame: Baseline, 30 hours after dosing initial dosing ]
  3. Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment [ Time Frame: Baseline, 30 hours after initial dosing ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Males and females between 18 and 50 years of age.
  2. Vital signs within normal limits on admission to the study: SpO2 > 94%, systolic blood pressure between 150-90 mm Hg, diastolic blood pressure between 100-60 mm Hg, afebrile.

Exclusion Criteria:

  1. Any chronic medical condition considered by the PI as a contraindication to receiving yT, including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, chronic thyroid disease, kidney disease or coagulation defects.
  2. Use of systemic or inhaled steroids.
  3. Use of NSAID or ASA within 48 hours of dosing, and inability to withhold these medications for the duration of the study.
  4. Use of anticoagulants including warfarin, heparin, clopidogrel or enoxaparin.
  5. Diagnosis of anemia or abnormal blood counts at screening
  6. Known vagal response to venipuncture
  7. Abnormal PT or PTT values at screening.
  8. BMI > 35
  9. Pregnant or breast feeding women will not be included.

Information from the National Library of Medicine

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


Locations
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United States, North Carolina
Center for Environmental Medicine, Asthma and Lung Biology
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Environmental Health Sciences (NIEHS)
Investigators
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Principal Investigator: David B. Peden, MD, MS University of North Carolina, Chapel Hill

Publications of Results:
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02610829     History of Changes
Other Study ID Numbers: 15-1291
5R01ES023349-03 ( U.S. NIH Grant/Contract )
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
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Tocopherols
Vitamin E
Tocotrienols
alpha-Tocopherol
gamma-Tocopherol
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances