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Completed

NCT Number: NCT02610829

Evaluation of a Short Course of Gamma Tocopherol Supplementation in Adult Subjects

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

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Environmental Medicine, Asthma and Lung Biology

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females between 18 and 50 years of age.
  • 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

  • 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.
  • Use of systemic or inhaled steroids.
  • Use of NSAID or ASA within 48 hours of dosing, and inability to withhold these medications for the duration of the study.
  • Use of anticoagulants including warfarin, heparin, clopidogrel or enoxaparin.
  • Diagnosis of anemia or abnormal blood counts at screening
  • Known vagal response to venipuncture
  • Abnormal PT or PTT values at screening.
  • BMI > 35
  • Pregnant or breast feeding women will not be included.

Treatment and study plan

Gamma tocopherol

Dietary Supplement

3 doses of 1400 mg gamma tocopherol (2 capsules, each is 700mg), at 12 hour intervals

Other names: Vitamin E

Primary outcomes

  1. Change in gamma tocopherol serum levels

    Time frame: Baseline, 30 hours after initial dosing

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute of Environmental Health Sciences (NIEHS)

Registry information

Acronym: Gammadose

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 20, 2015
Registry last updated
Apr 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.