Evaluation of a Short Course of Gamma Tocopherol Supplementation in Adult Subjects (Gammadose)

• ClinicalTrials.gov Identifier: NCT02610829
• Recruitment Status: Completed
• First Posted: November 20, 2015
• Last Update Posted: April 27, 2018
• Sponsor: University of North Carolina, Chapel Hill
• Collaborator: National Institute of Environmental Health Sciences (NIEHS)
• Information provided by (Responsible Party): University of North Carolina, Chapel Hill

Tracking Information

• First Submitted Date: November 6, 2015
• First Posted Date: November 20, 2015
• Last Update Posted Date: April 27, 2018
• Actual Study Start Date: November 2015
• Actual Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 19, 2015): Change in gamma tocopherol serum levels [ Time Frame: Baseline, 30 hours after initial dosing ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Gamma Tocopherol Serum Levels

Intervention

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

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 19, 2015): 10
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: February 2016
• Actual Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02610829
• Other Study ID Numbers: 15-1291; 5R01ES023349-03 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University of North Carolina, Chapel Hill
• Study Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute of Environmental Health Sciences (NIEHS)

Investigators

• 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