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CompletedNCT03444298SmokeyTUpdated Feb 5, 2024Results posted

A Study of Gamma Tocopherol-enriched Supplement on Lower Airway Responses to Inhaled Wood Smoke in Healthy Adults

A Phase 2 interventional study of Gamma Tocopherol and Placebo in Airway Inflammation and Asthma, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-05.

Sponsored by University of North Carolina, Chapel Hill · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

Purpose: To determine the efficacy of 1400 mg gamma tocopherol-enriched supplement for mitigating inhaled wood smoke particle-induced airway inflammation in healthy adults with no more than mild asthma.

Read the detailed description

Particulate matter (PM) is a leading cause of respiratory tract and cardiovascular disease in the United States and world-wide. Wood smoke particles (WSP) derived from wildland and other fires account for a significant fraction of ambient air PM. Health effects associated with WSP include acute bronchitis, asthma exacerbation, pneumonia, cough and systemic inflammation. While these effects are seen in both healthy and asthmatic individuals, many studies indicate that asthmatics have increased susceptibility to the effects of WSP. The investigators have developed a 500 μg/m3 WSP exposure protocol (levels similar to those encountered by firefighters and residents in close proximity to wildland burn sites) that induces airway and systemic inflammation in healthy volunteers. As with other pollutants, these inflammatory responses modulate non-specific bronchial reactivity (NSBR), inflammatory cell recruitment to the airways (primarily neutrophils), and potentially cardiovascular function.

The investigators have focused on gamma tocopherol (γT) as a nutritional intervention to prevent inflammatory responses to air pollutants such as WSP. Building on animal and in vitro preclinical studies, the investigators have established that 1400 mg/day of oral γT-enriched supplement for 7 and 14 days in healthy volunteers and mild asthmatics, respectively, inhibited neutrophil influx into the airways, reduced production of sputum mucins, and improved mucociliary clearance following challenge with inhaled endotoxin, another common component of PM. The findings occurred in the context of significantly increased plasma concentrations of γT and its active metabolite 2,7,8-trimethyl-2-(β-Carboxy-Ethyl)-6-Hydroxychroman (γ-CEHC). Given the findings in these early phase clinical trials, γT supplementation is an attractive approach to prevent WSP-induced adverse health effects. The investigators propose to use γT supplementation in a human model of WSP inhalation to mitigate key features of airway inflammation: inflammatory cell recruitment, production of inflammatory cytokines and mucous, and changes in airway physiology.

Gamma tocopherol will be administered in softgel form, with each softgel containing 700 mg of tocopherols, 89.5% of which is d-gamma tocopherol. Subjects will consume two softgels by mouth once daily for 7 days. This dosing regimen was chosen based on the results of the investigators' previous early phase clinical trials examining the impact of gamma tocopherol on lipopolysaccharide (LPS) -induced airway inflammation in healthy adults and adults with asthma. These studies tested a 7 and 14 day course of treatment, respectively, and found similar plasma concentrations of γT and active metabolites in both studies. Furthermore, the investigators showed in both studies that γT significantly reduced LPS-induced sputum neutrophilia compared to placebo. Based on the previous findings, the investigators will now study the efficacy of γT for mitigating WSP-induced airway inflammation.

January 2022 update: The existing, custom source of gamma tocopherol expired during the protocol paused period during Covid. The Gamma t is replaced by Gamma E Gems, manufactured by Carlson Labs, each capsule with 577mg of gamma tocopherol, based on Certificate of Analysis. Subjects will continue to ingest 2 capsules at each dosing, for a total dose of 1154mg. The safflower oil placebo is replaced with a neutral oil capsule.

02

Conditions studied

  • Airway Inflammation
  • Asthma

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03

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Age 18-45 years, inclusive, of both genders
  2. Negative pregnancy test for females who are not s/p hysterectomy with oophorectomy
  3. Forced expiratory volume at one second (FEV1) of at least 75% of predicted (without use of bronchodilating medications for 12 hours), consistent with lung function of persons with no more than mild intermittent or mild persistent asthma.
  4. Oxygen saturation of \<93% and blood pressure within the following limits: (Systolic between 150-85 mmHg, Diastolic between 90-50 mmHg).
  5. Ability to provide an induced sputum sample.
  6. Subject must demonstrate a ≥10% increase in sputum neutrophils following inhaled WSP exposure, when compared to baseline sputum (to be completed in a separate protocol).
  7. Ability/willingness to discontinue inhaled corticosteroids, montelukast, and cromolyn for 2 weeks without increased symptoms or increased need for beta agonist rescue medication prior to screening and through the course of the study.

Exclusion criteria

Exclusion Criteria

Patients who meet any of these criteria are not eligible for enrollment as study participants:

  1. Clinical contraindications:

    1. Any chronic medical condition considered by the PI as a contraindication to the exposure study including significant cardiovascular disease, diabetes, chronic renal disease, chronic thyroid disease, history of chronic infections/immunodeficiency.
    2. Viral upper respiratory tract infection within 4 weeks of challenge.
    3. Any acute infection requiring antibiotics within 4 weeks of exposure or fever of unknown origin within 4 weeks of challenge.
    4. Abnormal physical findings at the baseline visit, including but not limited to abnormalities on auscultation, temperature of 37.8° C, Systolic BP > 150mm Hg or \< 85 mm Hg; or Diastolic BP > 90 mm Hg or \< 50 mm Hg, or pulse oximetry saturation reading less than 93%.
    5. Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months.
    6. Moderate or severe asthma
    7. Exacerbation of asthma more than 2x/weeks which would be characteristic of a person with moderate or severe persistent asthma as outlined in the current National Asthma Education and Prevention Program (NAEPP) guidelines for diagnosis and management of asthma
    8. Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest tightness) which would be characteristic of a person with moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma (not to include prophylactic use of albuterol prior to exercise).
    9. Nighttime symptoms of cough or wheeze greater than 1x/week at baseline (not during a clearly recognized viral induced asthma exacerbation) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for the diagnosis and management of asthma.
    10. History of intubation for asthma
    11. If there is a history of allergic rhinitis, subjects must be asymptomatic of allergic rhinitis at the time of study enrollment.
    12. Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
    13. Cigarette smoking > 1 pack per month
    14. Unwillingness to use reliable contraception if sexually active (IUD, birth control pills/patch, condoms).
    15. Abnormal prothrombin time (PT) or activated partial thromboplastin time (aPTT) values at screening or during the treatment period. Normal values will be those published by the clinical lab (Labcorp, INC).
    16. Use of immunosuppressive or anticoagulant medications including routine use of NSAIDS. Oral contraceptives are acceptable, as are Antidepressants and other medications may be permitted if, in the opinion of the investigator, the medication will not interfere with the study procedures or compromise safety and if the dosage has been stable for 1 month.
    17. Orthopedic injuries or impediments that would preclude bicycle or treadmill exercise.
    18. Inability to avoid NSAIDS, Multivitamins, Vitamin C or E or herbal supplements.
    19. Allergy/sensitivity to study drugs or their formulations
    20. Known hypersensitivity to methacholine or to other parasympathomimetic agents
    21. Unwillingness to avoid coffee, tea, cola drinks, chocolate, or other foods containing caffeine after midnight on the days that methacholine challenge testing is to be performed.
  2. Pregnant/nursing women and children (\< 18 years as this is age of majority in North Carolina) will also be excluded since the risks associated with woodsmoke exposure to the fetus or child, respectively, are unknown and cannot be justified for this non-therapeutic protocol. Individuals over 45 years of age will not be included due to the increased possibility of co-morbidities and need for prohibited medications.
  3. Inability or unwillingness of a participant to give written informed consent.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
16 participants (actual)

Study arms

  • Placebo comparator
    Placebo first, then Gamma Tocopherol

    Participants that are randomized to placebo treatment will take a short treatment course of Neutral Oil followed by chamber exposure with wood smoke particulate. After a 4-week washout period, participants will cross over to the gamma Tocopherol (active) treatment group.

    Drug: Gamma Tocopherol · Drug: Placebo

  • Active comparator
    GammaTocopherol first, then Placebo

    Participants that are randomized γT treatment will take a short treatment course of gamma Tocopherol followed by chamber exposure with WSP. After a 4-week washout period, participants will cross over to the placebo treatment group.

    Drug: Gamma Tocopherol · Drug: Placebo

Interventions

  • DrugGamma Tocopherol

    Each dose consists of two (700 mg) capsules by mouth once daily for a total of 7 days.

    Also known as: Vitamin E

  • DrugPlacebo

    Each dose consists of two capsules by mouth once daily for a total of 7 days.

    Also known as: Neutral oil

05

What researchers measure

Primary outcomes

  1. Change in Sputum % Polymorphonuclear Neutrophils (PMN) With Wood Smoke Particulate (WSP) Exposure

    A comparison of the WSP-induced change in sputum % PMNs (Post-WSP sputum - Pre-WSP sputum) during gamma tocopherol treatment with the WSP-induced change in sputum % PMNs during placebo treatment.

    Time frame: baseline, and 4 hours post exposure

  2. Change in Sputum % PMNs With WSP Exposure

    A comparison of the WSP-induced change in sputum % PMNs (Post-WSP sputum - Pre-WSP sputum) during gamma tocopherol treatment with the WSP-induced change in sputum % PMNs during placebo treatment.

    Time frame: baseline, and 24 hours post exposure

Secondary outcomes

  1. Change in Absolute PMN Count (ANC) in Sputum With WSP Exposure

    A comparison of the WSP-induced change in sputum ANC (Post-WSP sputum - Pre-WSP sputum) during gamma tocopherol treatment with the WSP-induced change in sputum ANC during placebo treatment.

    Time frame: baseline, and 4 hours post exposure

  2. Change in Absolute PMN Count (ANC) in Sputum With WSP Exposure

    A comparison of the WSP-induced change in sputum ANC (Post-WSP sputum - Pre-WSP sputum) during gamma tocopherol treatment with the WSP-induced change in sputum ANC during placebo treatment.

    Time frame: baseline, and 24 hours post exposure

06

Results

Posted Feb 5, 2024

Participant flow

Period 1 (Dosing Followed by Exposure)
Participant flow — Period 1 (Dosing Followed by Exposure)
MilestonePlacebo First, Then Gamma TocopherolGammaTocopherol First, Then Placebo
Started79
Completed79
Not completed00
Washout (>/= 4 Weeks)
Participant flow — Washout (>/= 4 Weeks)
MilestonePlacebo First, Then Gamma TocopherolGammaTocopherol First, Then Placebo
Started79
Completed47
Not completed32
Period 2 (Dosing Followed by Exposure)
Participant flow — Period 2 (Dosing Followed by Exposure)
MilestonePlacebo First, Then Gamma TocopherolGammaTocopherol First, Then Placebo
Started47
Completed47
Not completed00

Outcome measures

PrimaryChange in Sputum % Polymorphonuclear Neutrophils (PMN) With Wood Smoke Particulate (WSP) Exposure

A comparison of the WSP-induced change in sputum % PMNs (Post-WSP sputum - Pre-WSP sputum) during gamma tocopherol treatment with the WSP-induced change in sputum % PMNs during placebo treatment.

Time frame:
baseline, and 4 hours post exposure
Reported as:
Mean · percent PMNs
Change in Sputum % Polymorphonuclear Neutrophils (PMN) With Wood Smoke Particulate (WSP) Exposure
percent PMNsGammaTocopherolPlacebo
Change in Sputum % Polymorphonuclear Neutrophils (PMN) With Wood Smoke Particulate (WSP) Exposure18.00 ± 20.8914.75 ± 17.98
Statistical analysis
  • GammaTocopherol vs Placebo · t-test, 2 sided · p = 0.67 (The a priori threshold for statistical significance is \<0.05.)
PrimaryChange in Sputum % PMNs With WSP Exposure

A comparison of the WSP-induced change in sputum % PMNs (Post-WSP sputum - Pre-WSP sputum) during gamma tocopherol treatment with the WSP-induced change in sputum % PMNs during placebo treatment.

Time frame:
baseline, and 24 hours post exposure
Reported as:
Mean · percent PMNs
Change in Sputum % PMNs With WSP Exposure
percent PMNsGammaTocopherolPlacebo
Change in Sputum % PMNs With WSP Exposure39.87 ± 20.5929.35 ± 28.30
Statistical analysis
  • GammaTocopherol vs Placebo · Mixed Models Analysis · p = 0.43 (The a priori threshold for statistical significance is \<0.05.)
SecondaryChange in Absolute PMN Count (ANC) in Sputum With WSP Exposure

A comparison of the WSP-induced change in sputum ANC (Post-WSP sputum - Pre-WSP sputum) during gamma tocopherol treatment with the WSP-induced change in sputum ANC during placebo treatment.

Time frame:
baseline, and 4 hours post exposure
Reported as:
Mean · PMNs per mg sputum
Change in Absolute PMN Count (ANC) in Sputum With WSP Exposure
PMNs per mg sputumGammaTocopherolPlacebo
Change in Absolute PMN Count (ANC) in Sputum With WSP Exposure8.58 ± 150.6-20.51 ± 160.6
Statistical analysis
  • GammaTocopherol vs Placebo · t-test, 2 sided · p = 0.27 (The a priori threshold for statistical significance is \<0.05.)
SecondaryChange in Absolute PMN Count (ANC) in Sputum With WSP Exposure

A comparison of the WSP-induced change in sputum ANC (Post-WSP sputum - Pre-WSP sputum) during gamma tocopherol treatment with the WSP-induced change in sputum ANC during placebo treatment.

Time frame:
baseline, and 24 hours post exposure
Reported as:
Mean · PMNs per mg sputum
Change in Absolute PMN Count (ANC) in Sputum With WSP Exposure
PMNs per mg sputumGammaTocopherolPlacebo
Change in Absolute PMN Count (ANC) in Sputum With WSP Exposure104.7 ± 146.596.7 ± 156.2
Statistical analysis
  • GammaTocopherol vs Placebo · t-test, 2 sided · p = 0.92 (The a priori threshold for statistical significance is \<0.05.)
Post-hocPercent Eosinophils in Sputum

A comparison of the WSP-induced sputum % eosinophils versus predosing values with gamma tocopherol and placebo treatment.

Time frame:
up to 24 hours
Reported as:
Mean · percent eosinophils
Percent Eosinophils in Sputum
percent eosinophilsPre-DosingGammaTocopherolPlacebo
4 Hours0.07 ± 0.040.04 ± 0.082.3 ± 1.6
24 Hours0.07 ± 0.040.26 ± 0.150.39 ± 0.33
Statistical analysis
  • Pre-Dosing vs GammaTocopherol · Mixed Models Analysis · p = 0.99 (The a priori threshold for statistical significance is \<0.05.)
  • Pre-Dosing vs Placebo · Mixed Models Analysis · p = 0.04 (The a priori threshold for statistical significance is \<0.05.)
Post-hocEosinophils Per mg Sputum

A comparison of the WSP-induced sputum eosinophils after gamma tocopherol and placebo pre dosing values.

Time frame:
up to 24 hours
Reported as:
Mean · Cells per mg (eosinophils)
Eosinophils Per mg Sputum
Cells per mg (eosinophils)Pre-DosingGammaTocopherolPlacebo
4 Hours0.17 ± 0.330.20 ± 0.527.10 ± 12.33
24 Hours0.17 ± 0.331.15 ± 2.111.02 ± 2.70
Statistical analysis
  • Pre-Dosing vs GammaTocopherol · Mixed Models Analysis · p = 0.98 (The a priori threshold for statistical significance is \<0.05.)
  • Pre-Dosing vs Placebo · Mixed Models Analysis · p = 0.02 (The a priori threshold for statistical significance is \<0.05.)
Post-hocInterleukin-1 Beta (IL-1β) in Sputum

The IL-1β concentration will be determined in each sputum sample by immunoassay

Time frame:
up to 24 hours
Reported as:
Mean · pg/mL
Interleukin-1 Beta (IL-1β) in Sputum
pg/mLPre-DosingGammaTocopherolPlacebo
4 Hours798.3 ± 497.1674.2 ± 494.9654.4 ± 438.3
24 Hours798.3 ± 497.1469.6 ± 237.4675.2 ± 630.6
Statistical analysis
  • Pre-Dosing vs GammaTocopherol vs Placebo · Mixed Models Analysis · p = 0.84 (The a priori threshold for statistical significance is \<0.05.)
Post-hocInterleukin-6 (IL-6) in Sputum

The IL-6 concentration will be determined in each sputum sample by immunoassay

Time frame:
up to 24 hours
Reported as:
Mean · pg/mL
Interleukin-6 (IL-6) in Sputum
pg/mLPre-DosingGammaTocopherolPlacebo
4 Hours458.0 ± 492.3384.8 ± 440.2277.5 ± 255.5
24 Hours458.0 ± 492.3207.0 ± 171.6281.3 ± 338.0
Statistical analysis
  • Pre-Dosing vs GammaTocopherol vs Placebo · Mixed Models Analysis · p = 0.59 (The a priori threshold for statistical significance is \<0.05.)
Post-hocInterleukin-8 (IL-8) in Sputum

The IL-8 concentration will be determined in each sputum sample by immunoassay

Time frame:
up to 24 hours
Reported as:
Mean · pg/mL
Interleukin-8 (IL-8) in Sputum
pg/mLPre-DosingGammaTocopherolPlacebo
4 Hours30850 ± 2830631724 ± 3750525432 ± 23198
24 Hours30850 ± 2830617180 ± 1308336739 ± 60134
Statistical analysis
  • Pre-Dosing vs GammaTocopherol vs Placebo · Mixed Models Analysis · p = 0.83 (The a priori threshold for statistical significance is \<0.05.)
Post-hocTumor Necrosis Factor-alpha (TNF-a)

The TNF-a concentration will be determined in each sputum sample by immunoassay

Time frame:
up to 24 hours
Reported as:
Mean · pg/mL
Tumor Necrosis Factor-alpha (TNF-a)
pg/mLPre-DosingGammaTocopherolPlacebo
4 Hours35.67 ± 25.88127.7 ± 342.725.18 ± 20.84
24 Hours35.67 ± 25.8813.77 ± 12.6329.23 ± 26.18
Statistical analysis
  • Pre-Dosing vs GammaTocopherol vs Placebo · Mixed Models Analysis · p = 0.51 (The a priori threshold for statistical significance is \<0.05.)
Post-hocAlpha Tocopherol in Blood

The alpha tocopherol concentration will be determined in blood samples by high-performance liquid chromatography (HPLC).

Time frame:
Baseline immediately before WSP challenge
Reported as:
Mean · microM
Alpha Tocopherol in Blood
microMGammaTocopherolPlacebo
Alpha Tocopherol in Blood22.54 ± 10.1724.58 ± 3.40
Statistical analysis
  • GammaTocopherol vs Placebo · t-test, 2 sided · p = 0.48 (The a priori threshold for statistical significance is \<0.05.)
Post-hoc2, 7,8-trimethyl-2S-(G-carboxyethyl)-6-hydroxychromane (g-CEHC) in Blood

The 2, 7,8-trimethyl-2S-(g-carboxyethyl)-6-hydroxychromane (g-CEHC) concentration will be determined in blood samples by high-performance liquid chromatography (HPLC).

Time frame:
Baseline immediately before WSP challenge
Reported as:
Mean · microM
2, 7,8-trimethyl-2S-(G-carboxyethyl)-6-hydroxychromane (g-CEHC) in Blood
microMGammaTocopherolPlacebo
2, 7,8-trimethyl-2S-(G-carboxyethyl)-6-hydroxychromane (g-CEHC) in Blood1.912 ± 2.0210.084 ± 0.08
Statistical analysis
  • GammaTocopherol vs Placebo · t-test, 2 sided · p = <0.01 (The a priori threshold for statistical significance is \<0.05.)
Post-hocGammaTocopherol in Blood

The gamma tocopherol concentration will be determined in blood samples by high-performance liquid chromatography (HPLC).

Time frame:
Baseline immediately before WSP challenge
Reported as:
Mean · microM
GammaTocopherol in Blood
microMGammaTocopherolPlacebo
GammaTocopherol in Blood32.60 ± 7.454.64 ± 1.71
Statistical analysis
  • GammaTocopherol vs Placebo · t-test, 2 sided · p = <0.0001 (The a priori threshold for statistical significance is \<0.05.)

Adverse events

Collected over From the time a participant signed consent through completion of the second intervention, a total of up to 5 months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
GammaTocopherol0/13 (0%)0/13 (0%)8/13 (61.5%)
Placebo0/14 (0%)0/14 (0%)7/14 (50%)
Most frequent other events
Showing 10 of 17
Most frequent other events
EventGammaTocopherolPlacebo
Gastrointestinal DistressGastrointestinal disorders7/132/14
HeadacheGeneral disorders2/133/14
Viral Upper Respiratory InfectionRespiratory, thoracic and mediastinal disorders1/131/14
Eye IrritationEye disorders1/130/14
NosebleedVascular disorders1/130/14
Unusual Fatigue or TirednessGeneral disorders1/131/14
Premature Ventricular ContractionCardiac disorders1/130/14
Menstrual CrampsGeneral disorders1/130/14
SweatingSkin and subcutaneous tissue disorders1/131/14
Throat IrritationRespiratory, thoracic and mediastinal disorders1/130/14

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Placebo First, Then Gamma TocopherolGammaTocopherol First, Then PlaceboTotal
<=18 years000
Between 18 and 65 years7916
>=65 years0000
Sex: Female, Male
Sex: Female, Male(Participants)Placebo First, Then Gamma TocopherolGammaTocopherol First, Then PlaceboTotal
Female6511
Male145
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Placebo First, Then Gamma TocopherolGammaTocopherol First, Then PlaceboTotal
Hispanic or Latino224
Not Hispanic or Latino5712
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Placebo First, Then Gamma TocopherolGammaTocopherol First, Then PlaceboTotal
American Indian or Alaska Native000
Asian101
Native Hawaiian or Other Pacific Islander000
Black or African American314
White3811
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(Participants)Placebo First, Then Gamma TocopherolGammaTocopherol First, Then PlaceboTotal
United States7916
07

Study locations

1 site
  • UNC Center for Environmental Medicine, Asthma and Lung Biology
    Chapel Hill, North Carolina 27599, United States
08

References and documents

Publications

  • Burbank AJ, Duran CG, Almond M, Wells H, Jenkins S, Jiang Q, Yang C, Wang T, Zhou H, Hernandez ML, Peden DB. A short course of gamma-tocopherol mitigates LPS-induced inflammatory responses in humans ex vivo. J Allergy Clin Immunol. 2017 Oct;140(4):1179-1181.e4. doi: 10.1016/j.jaci.2017.04.030. Epub 2017 May 12. No abstract available. PubMed 28506847 ↗
  • Hernandez ML, Wagner JG, Kala A, Mills K, Wells HB, Alexis NE, Lay JC, Jiang Q, Zhang H, Zhou H, Peden DB. Vitamin E, gamma-tocopherol, reduces airway neutrophil recruitment after inhaled endotoxin challenge in rats and in healthy volunteers. Free Radic Biol Med. 2013 Jul;60:56-62. doi: 10.1016/j.freeradbiomed.2013.02.001. Epub 2013 Feb 9. PubMed 23402870 ↗
  • 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. PubMed 18405673 ↗
  • Burbank AJ, Duran CG, Pan Y, Burns P, Jones S, Jiang Q, Yang C, Jenkins S, Wells H, Alexis N, Kesimer M, Bennett WD, Zhou H, Peden DB, Hernandez ML. Gamma tocopherol-enriched supplement reduces sputum eosinophilia and endotoxin-induced sputum neutrophilia in volunteers with asthma. J Allergy Clin Immunol. 2018 Apr;141(4):1231-1238.e1. doi: 10.1016/j.jaci.2017.06.029. Epub 2017 Jul 20. PubMed 28736267 ↗
  • Peden DB, Almond M, Brooks C, Robinette C, Wells H, Burbank A, Hernandez M, Hinderliter A, Caughey M, Jiang Q, Wang Q, Li H, Zhou H, Alexis N. A pilot randomized clinical trial of gamma-tocopherol supplementation on wood smoke-induced neutrophilic and eosinophilic airway inflammation. J Allergy Clin Immunol Glob. 2023 Oct 5;2(4):100177. doi: 10.1016/j.jacig.2023.100177. eCollection 2023 Nov. PubMed 37876758 ↗

Study documents

  • Protocol and statistical analysis plan · Jan 24, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03444298
Lead sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Environmental Health Sciences (NIEHS)
Responsible party
Sponsor
First posted
Feb 23, 2018
Start date
Jun 8, 2018
Primary completion
Mar 2, 2023
Completion
Mar 6, 2023
Results posted
Feb 5, 2024
Last update
Feb 5, 2024

Study contacts

David Peden, MD
principal investigator · UNC

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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