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Trial record 3 of 702 for:    tocotrienols

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

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
 (submitted: November 19, 2015)
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
 (submitted: November 19, 2015)
  • 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 ]
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
 (submitted: November 19, 2015)
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:

  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Principal Investigator: David B. Peden, MD, MS University of North Carolina, Chapel Hill
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