Trial Outcomes & Findings for Study on the Role of Treatment With Vitamin E on Asthmatic Responses in Allergic Asthmatics (NCT NCT00581048)
NCT ID: NCT00581048
Last Updated: 2018-03-29
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
33 participants
Primary outcome timeframe
At baseline to after 16-18 weeks of treatment with vitamin E daily
Results posted on
2018-03-29
Participant Flow
Participant milestones
| Measure |
Natural Source d-α-tocopheryl Acetate
1500 units daily for 16 weeks
Natural source d-α-tocopheryl acetate: 1500 units daily for 16 weeks
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study on the Role of Treatment With Vitamin E on Asthmatic Responses in Allergic Asthmatics
Baseline characteristics by cohort
| Measure |
Natural Source d-α-tocopheryl Acetate
n=33 Participants
1500 units daily for 16 weeks
Natural source d-α-tocopheryl acetate: 1500 units daily for 16 weeks
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At baseline to after 16-18 weeks of treatment with vitamin E dailyPopulation: Underlying data was lost. Go to https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3476459 Figure 1 for diagram of results
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and After 16-18 weeks of treatment with vitamin EPopulation: Underlying data was lost. Go to https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3476459 Figure 2 for diagram of results
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to after 16-18 weeks of treatment with vitamin E dailyOutcome measures
| Measure |
Before Treatment, Baseline
n=33 Participants
|
After Treatment
n=33 Participants
|
|---|---|---|
|
Allergen-provoked Concentrations of Th1 and Th2 Cytokines in BAL
IL-1B
|
0.97 pg/mL
Interval 0.3 to 1.69
|
1.21 pg/mL
Interval 0.52 to 1.98
|
|
Allergen-provoked Concentrations of Th1 and Th2 Cytokines in BAL
IL-2
|
0.48 pg/mL
Interval 0.2 to 0.99
|
0.69 pg/mL
Interval 0.23 to 1.48
|
|
Allergen-provoked Concentrations of Th1 and Th2 Cytokines in BAL
IL-9
|
0 pg/mL
Interval 0.0 to 6.25
|
0 pg/mL
Interval 0.0 to 5.6
|
|
Allergen-provoked Concentrations of Th1 and Th2 Cytokines in BAL
IL-10
|
0.53 pg/mL
Interval 0.29 to 1.09
|
0.7 pg/mL
Interval 0.25 to 1.18
|
|
Allergen-provoked Concentrations of Th1 and Th2 Cytokines in BAL
IL-13
|
0.6 pg/mL
Interval 0.4 to 1.96
|
1.0 pg/mL
Interval 0.075 to 3.6
|
|
Allergen-provoked Concentrations of Th1 and Th2 Cytokines in BAL
TNF-a
|
2.76 pg/mL
Interval 0.65 to 11.6
|
3.02 pg/mL
Interval 0.96 to 14.3
|
|
Allergen-provoked Concentrations of Th1 and Th2 Cytokines in BAL
IL-3
|
1.6 pg/mL
Interval 0.0 to 7.7
|
1.4 pg/mL
Interval 0.0 to 4.5
|
|
Allergen-provoked Concentrations of Th1 and Th2 Cytokines in BAL
IL-4
|
0.17 pg/mL
Interval 0.03 to 0.57
|
0.045 pg/mL
Interval 0.0 to 0.2
|
|
Allergen-provoked Concentrations of Th1 and Th2 Cytokines in BAL
IL-5
|
1.0 pg/mL
Interval 0.33 to 2.9
|
0.8 pg/mL
Interval 0.41 to 13.6
|
|
Allergen-provoked Concentrations of Th1 and Th2 Cytokines in BAL
IL-6
|
21.5 pg/mL
Interval 5.55 to 111.9
|
17 pg/mL
Interval 4.35 to 94.6
|
|
Allergen-provoked Concentrations of Th1 and Th2 Cytokines in BAL
IL-12
|
0.05 pg/mL
Interval 0.002 to 0.21
|
0.165 pg/mL
Interval 0.078 to 0.41
|
|
Allergen-provoked Concentrations of Th1 and Th2 Cytokines in BAL
INF-Y
|
0.49 pg/mL
Interval 0.23 to 0.96
|
0.7 pg/mL
Interval 0.3 to 1.65
|
|
Allergen-provoked Concentrations of Th1 and Th2 Cytokines in BAL
CXCL8
|
44.0 pg/mL
Interval 25.2 to 93.5
|
53.2 pg/mL
Interval 31.0 to 92.3
|
|
Allergen-provoked Concentrations of Th1 and Th2 Cytokines in BAL
CCL5
|
3.0 pg/mL
Interval 1.36 to 7.11
|
2.3 pg/mL
Interval 1.71 to 8.34
|
|
Allergen-provoked Concentrations of Th1 and Th2 Cytokines in BAL
CCL11
|
1.0 pg/mL
Interval 0.0 to 4.02
|
2.70 pg/mL
Interval 0.0 to 5.45
|
SECONDARY outcome
Timeframe: baseline to after 16-18 weeks of treatment with vitamin E dailyOutcome measures
| Measure |
Before Treatment, Baseline
n=33 Participants
|
After Treatment
n=33 Participants
|
|---|---|---|
|
Allergen-provoked Concentrations of Immunoglobulin E (IgE) in BAL
|
4.05 UI/ml
Interval 2.81 to 10.8
|
3.65 UI/ml
Interval 2.87 to 12.9
|
Adverse Events
Natural Source d-α-tocopheryl Acetate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place