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Effect of Gamma Tocopherol Enriched Supplementation on Response to Inhaled O3 Exposure (Gammoz)

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ClinicalTrials.gov Identifier: NCT02911688
Recruitment Status : Completed
First Posted : September 22, 2016
Results First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
National Institute of Environmental Health Sciences (NIEHS)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Allergic Asthma
Interventions Drug: gamma tocopherol
Drug: Placebo
Enrollment 18
Recruitment Details Volunteers were screened for eligibility between September 2016 and November 2018 at the Center for Environmental Medicine, Asthma and Lung Biology at the University of North Carolina at Chapel Hill.
Pre-assignment Details 18 volunteers were randomized
Arm/Group Title Placebo Then Gamma T Gamma Tocopherol Then Placebo
Hide Arm/Group Description Participants first received safflower oil, taken in two 700 mg capsules every 12 hours for a total of 4 doses followed by a washout period of at least 3 weeks. Then they received gamma tocopherol-enriched supplement taken in two 700 mg capsules (total of 1200 mg of gamma tocopherol) every 12 hours for a total of 4 doses. Participants first received gamma tocopherol-enriched supplement taken in two 700 mg capsules (total of 1200 mg of gamma tocopherol) every 12 hours for a total of 4 doses, followed by a washout period of at least 3 weeks. They then received safflower oil, taken in two 700 mg capsules every 12 hours for a total of 4 doses.
Period Title: First Intervention
Started 9 9
Received Intervention 9 9
Completed 9 9
Not Completed 0 0
Period Title: Washout
Started 9 9
Completed 8 7
Not Completed 1 2
Reason Not Completed
Lost to Follow-up             1             1
Withdrawal by Subject             0             1
Period Title: Second Intervention
Started 8 7
Completed 8 7
Not Completed 0 0
Arm/Group Title Placebo Then Gamma T Gamma Tocopherol Then Placebo Total
Hide Arm/Group Description Safflower oil, taken in 2 capsules every 12 hours for a total of 4 doses followed by a washout period of at least 3 weeks and then gamma tocopherol will be taken as 2 gel tabs (1200 mg/dose) every 12 hours for a total of 4 doses. Gamma tocopherol will be taken 2 gel tabs (1200 mg/dose) every 12 hours for a total of 4 doses followed by a washout period of at least 3 weeks followed by safflower oil, taken in 2 capsules every 12 hours for a total of 4 doses. Total of all reporting groups
Overall Number of Baseline Participants 9 9 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 18 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
 100.0%
9
 100.0%
18
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 18 participants
Female
8
  88.9%
5
  55.6%
13
  72.2%
Male
1
  11.1%
4
  44.4%
5
  27.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 18 participants
Hispanic or Latino
1
  11.1%
0
   0.0%
1
   5.6%
Not Hispanic or Latino
8
  88.9%
9
 100.0%
17
  94.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 18 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
  22.2%
0
   0.0%
2
  11.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  11.1%
1
  11.1%
2
  11.1%
White
6
  66.7%
8
  88.9%
14
  77.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 9 participants 9 participants 18 participants
9
 100.0%
9
 100.0%
18
 100.0%
1.Primary Outcome
Title Change From Baseline in Sputum Percent Neutrophils (%PMN) Following Ozone Exposure
Hide Description Participants provide induced sputum samples before and 6 hours after Ozone exposure for measurements of inflammatory cells. The analysis will determine if gamma tocopherol pre-treatment reduces ozone-induced sputum percent neutrophils compared to placebo pre-treatment.
Time Frame baseline and 6 hours post-ozone exposure
Hide Outcome Measure Data
Hide Analysis Population Description
Due to variability in quality of induced sputum samples, paired assessments of pre and post-ozone sputum endpoints were limited to 7 volunteers.
Arm/Group Title Gamma Tocopherol (N=7) Placebo (N=7)
Hide Arm/Group Description:
gamma tocopherol 1400 mg, taken as two 700 mg capsules every 12 hours for a total of 4 doses
Safflower oil, taken in 2 capsules every 12 hours for a total of 4 doses
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: percent neutrophils
34.1  (20.2) 36.5  (20.2)
2.Secondary Outcome
Title Change in Sputum Percent Eosinophils From Baseline Following Ozone Exposure
Hide Description The investigators assessed induced sputum cellularity at baseline and 6 hours after ozone exposure to determine if treatment with gamma tocopherol/placebo impacts ozone-induced sputum eosinophilia.
Time Frame baseline and 6 hours post-ozone exposure
Hide Outcome Measure Data
Hide Analysis Population Description
Due to variability in quality of induced sputum samples, paired assessments of pre and post-ozone sputum endpoints were limited to 7 volunteers.
Arm/Group Title Gamma Tocopherol (N=7) Placebo (N=7)
Hide Arm/Group Description:
gamma tocopherol 1400 mg, taken as two 700 mg capsules every 12 hours for a total of 4 doses
Safflower oil, taken in 2 capsules every 12 hours for a total of 4 doses
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: percent eosinophils
0.8  (3.7) -1.1  (3.0)
3.Secondary Outcome
Title Change in Sputum Interleukin (IL)-1b From Baseline Following Ozone Exposure
Hide Description Participants provide induced sputum samples before and 6 hours after Ozone exposure for measurements of inflammatory cytokines. The analysis will determine if gamma tocopherol pre-treatment reduces ozone-induced sputum inflammatory cytokine production compared to placebo pre-treatment.
Time Frame baseline and 6 hours post ozone exposure
Hide Outcome Measure Data
Hide Analysis Population Description
Sufficient paired sputum supernatants from pre and post-ozone were available for analysis from 15 volunteers.
Arm/Group Title Gamma Tocopherol Placebo
Hide Arm/Group Description:
gamma tocopherol 1400 mg, taken as two 700 mg capsules every 12 hours for a total of 4 doses
Safflower oil, taken in 2 capsules every 12 hours for a total of 4 doses
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: picograms per milliliter
-9.7  (65.9) 176  (687)
4.Secondary Outcome
Title Change in Sputum IL-6 From Baseline Following Ozone Exposure
Hide Description Participants provide induced sputum samples before and 6 hours after Ozone exposure for measurements of inflammatory cytokines. The analysis will determine if gamma tocopherol pre-treatment reduces ozone-induced sputum inflammatory cytokine production compared to placebo pre-treatment.
Time Frame baseline and 6 hours post ozone exposure
Hide Outcome Measure Data
Hide Analysis Population Description
Sufficient paired sputum supernatants from pre and post-ozone were available for analysis from 15 volunteers.
Arm/Group Title Gamma Tocopherol Placebo
Hide Arm/Group Description:
gamma tocopherol 1400 mg, taken as two 700 mg capsules every 12 hours for a total of 4 doses
Safflower oil, taken in 2 capsules every 12 hours for a total of 4 doses
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: picograms per milliliter
58.0  (225.5) 44.3  (128.3)
5.Secondary Outcome
Title Change in Sputum IL-8 From Baseline Following Ozone Exposure
Hide Description Participants provide induced sputum samples before and 6 hours after Ozone exposure for measurements of inflammatory cytokines. The analysis will determine if gamma tocopherol pre-treatment reduces ozone-induced sputum inflammatory cytokine production compared to placebo pre-treatment.
Time Frame baseline and 6 hours post ozone exposure
Hide Outcome Measure Data
Hide Analysis Population Description
Sufficient paired sputum supernatants from pre and post-ozone were available for analysis from 12 volunteers.
Arm/Group Title Gamma Tocopherol Placebo
Hide Arm/Group Description:
gamma tocopherol 1400 mg, taken as two 700 mg capsules every 12 hours for a total of 4 doses
Safflower oil, taken in 2 capsules every 12 hours for a total of 4 doses
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: picograms per milliliter
-341.1  (3027) 406.8  (2769)
6.Secondary Outcome
Title Change in Sputum Tumor Necrosis Factor (TNF)-Alpha From Baseline Following Ozone Exposure
Hide Description Participants provide induced sputum samples before and 6 hours after Ozone exposure for measurements of inflammatory cytokines. The analysis will determine if gamma tocopherol pre-treatment reduces ozone-induced sputum inflammatory cytokine production compared to placebo pre-treatment.
Time Frame baseline and 6 hours post ozone exposure
Hide Outcome Measure Data
Hide Analysis Population Description
Sufficient paired sputum supernatants from pre and post-ozone were available for analysis from 13 volunteers.
Arm/Group Title Gamma Tocopherol Placebo
Hide Arm/Group Description:
gamma tocopherol 1400 mg, taken as two 700 mg capsules every 12 hours for a total of 4 doses
Safflower oil, taken in 2 capsules every 12 hours for a total of 4 doses
Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: picograms per milliliter
-61.1  (179.1) -301.4  (1090)
7.Secondary Outcome
Title Change in Sputum Mucins From Baseline Following Ozone Exposure
Hide Description Participants provide induced sputum samples before and 6 hours after Ozone exposure for measurements of sputum mucins to determine if gamma tocopherol pre-treatment reduces ozone-induced sputum mucins compared to placebo pre-treatment.
Time Frame baseline and 6 hours post ozone exposure
Hide Outcome Measure Data
Hide Analysis Population Description
Due to improper processing of the sputum samples, analysis of mucins could not be performed.
Arm/Group Title Gamma Tocopherol Placebo
Hide Arm/Group Description:
gamma tocopherol 1400 mg, taken as two 700 mg capsules every 12 hours for a total of 4 doses
Safflower oil, taken in 2 capsules every 12 hours for a total of 4 doses
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Change in Whole Lung Clearance of Technetium Sulfur Colloid Particles (0-120 Minutes) From Baseline Following Ozone Exposure
Hide Description Whole lung clearance was measured using gamma scintigraphy and represented as mean average 120 minute clearance of inhaled technetium (99mTc) sulfur colloid particles in order to estimate the rate of airway mucociliary clearance.
Time Frame baseline and 1 hour after exiting ozone chamber
Hide Outcome Measure Data
Hide Analysis Population Description
This population includes those participants who completed both arms of the study (paired assessments of MCC). One participant could not complete the whole lung clearance scan during one of the study periods and was excluded from the analysis.
Arm/Group Title Gamma Tocopherol Placebo
Hide Arm/Group Description:
gamma tocopherol 1400 mg, taken as two 700 mg capsules every 12 hours for a total of 4 doses
Safflower oil, taken in 2 capsules every 12 hours for a total of 4 doses
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: % clearance
2  (7) 0  (7)
9.Post-Hoc Outcome
Title Change in Central Lung Clearance of Technetium Sulfur Colloid Particles (0-30 Minutes) From Baseline Following Ozone Exposure
Hide Description Central lung clearance (0-30 minutes) was measured using gamma scintigraphy and represented as mean average 30 minute clearance of inhaled technetium (99mTc) sulfur colloid particles from the large bronchial airways.
Time Frame baseline and 1 hour after exiting ozone chamber
Hide Outcome Measure Data
Hide Analysis Population Description
This population includes those participants who completed both arms of the study (paired assessments of MCC). One participant could not complete the whole lung clearance scan during one of the study periods and was excluded from the analysis.
Arm/Group Title Gamma Tocopherol Placebo
Hide Arm/Group Description:
gamma tocopherol 1400 mg, taken as two 700 mg capsules every 12 hours for a total of 4 doses
Safflower oil, taken in 2 capsules every 12 hours for a total of 4 doses
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: % clearance
-0.2  (8.3) -4.3  (5.0)
Time Frame Adverse event data was collected from the time of enrollment until the final study visit, occurring 5-10 days after the final ozone exposure (approximately 3 months and up to 6 months). If adverse events were reported at the final study visit, the participant was followed until resolution of the event.
Adverse Event Reporting Description Participants completed a standardized symptom questionnaire before ozone exposure and again at 6 and 24 hours after ozone exposure. They also completed a standardized symptom questionnaire each day while taking study treatment. Participants also had the opportunity to self-report adverse events.
 
Arm/Group Title Gamma Tocopherol Placebo
Hide Arm/Group Description gamma tocopherol 1400 mg, taken as 2 700 mg capsules every 12 hours for a total of 4 doses Safflower oil, taken in 2 capsules every 12 hours for a total of 4 doses
All-Cause Mortality
Gamma Tocopherol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)      0/16 (0.00%)    
Hide Serious Adverse Events
Gamma Tocopherol Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/17 (0.00%)      0/16 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Gamma Tocopherol Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/17 (35.29%)      1/16 (6.25%)    
Gastrointestinal disorders     
GI Distress  [1]  5/17 (29.41%)  6 1/16 (6.25%)  1
General disorders     
nasal soreness * [2]  1/17 (5.88%)  1 0/16 (0.00%)  0
headache  [3]  0/17 (0.00%)  0 1/16 (6.25%)  1
Respiratory, thoracic and mediastinal disorders     
URI * [4]  1/17 (5.88%)  1 1/16 (6.25%)  1
Pain on deep inspiration  [5]  2/17 (11.76%)  2 0/16 (0.00%)  0
Shortness of Breath  [6]  1/17 (5.88%)  1 0/16 (0.00%)  0
Wheezing  [7]  1/17 (5.88%)  1 0/16 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Abdominal cramping, diarrhea, nausea,vomiting
*
Indicates events were collected by non-systematic assessment
[2]
nasal turbinate soreness
[3]
headache
[4]
Upper respiratory Infection
[5]
pain on deep inspiration following ozone exposure
[6]
Mild shortness of breath
[7]
self-reported wheezing on questionnaire after ozone exposure
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Carole Robinette Assistant Director of Clinical Research
Organization: Center for Environmental Medicine Asthma and Lung Biology
Phone: 919 966-5638
EMail: carole_robinette@med.unc.edu
Layout table for additonal information
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02911688    
Other Study ID Numbers: 15-1938
4R01ES023349-04 ( U.S. NIH Grant/Contract )
First Submitted: September 8, 2016
First Posted: September 22, 2016
Results First Submitted: December 19, 2019
Results First Posted: January 18, 2020
Last Update Posted: January 18, 2020