Expired Study
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Chapel Hill, North Carolina 27599


Purpose:

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


Study summary:

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.


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.


Study is Available At:


Original ID:

15-1291


NCT ID:

NCT02610829


Secondary ID:

5R01ES023349-03


Study Acronym:

Gammadose


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

50 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of North Carolina, Chapel Hill


Oversight Authority:

  • United States: Institutional Review Board
  • United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

10


Enrollment Type:

Actual


Overall Contact Information

Official Name:David B. Peden, MD, MS
Principal Investigator
University of North Carolina, Chapel Hill

Study Dates

Start Date:November 2015
Completion Date:February 2016
Completion Type:Actual
Primary Completion Date:February 2016
Primary Completion Type:Actual
Verification Date:April 2018
Last Changed Date:April 25, 2018
First Received Date:November 6, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Time Frame:Baseline, 30 hours after initial dosing
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in 5-NO-gamma tocopherol
Time Frame:Baseline, 30 hours after dosing initial dosing
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in gamma-CEHC
Time Frame:Baseline, 30 hours after dosing initial dosing
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Change in gamma tocopherol serum levels
Time Frame:Baseline, 30 hours after initial dosing
Safety Issues:False

Study Interventions

Intervention Type:Dietary Supplement
Name:Gamma tocopherol
Description:3 doses of 1400 mg gamma tocopherol (2 capsules, each is 700mg), at 12 hour intervals
Arm Name:Gamma Tocopherol
Other Name:Vitamin E

Study Arms

Study Arm Type:Experimental
Arm Name:Gamma Tocopherol
Description:Subjects will ingest 1400 mg gamma tocopherol, orally administered in 3 doses separated by 12 hours.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of North Carolina, Chapel Hill
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Environmental Health Sciences (NIEHS)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation: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.
PMID:18405673

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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