Vitamin C & Exercise Induced Bronchoconstriction (EIB)
Primary Purpose
Exercise-induced Bronchospasm
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin C
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Exercise-induced Bronchospasm
Eligibility Criteria
Inclusion Criteria:
- Student or student-athlete who has tested positive for EIB
- Able to communicate in English
Exclusion Criteria:
- Forced expiratory volume in 1 second (FEV1) < 70% of predicted, cardiac history,
- Current respiratory infection
- > 10 pack year history of smoking
- Pregnancy.
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Vitamin C
Placebo
Arm Description
Participants will ingest 3 (500 mg) capsules of Vitamin C each day for 2 weeks.
Participants will ingest a matched capsule for size and color to the Vitamin C supplement.
Outcomes
Primary Outcome Measures
Change in airway inflammatory biomarkers
Urinary concentrations of cysteine leukotrienes (LTC4-LTE4), prostaglandin (9α,11β-PGF2), and creatinine will be measured.
Secondary Outcome Measures
Change in quality of life: asthma quality of life questionnaire (AQLQ)
Asthma specific quality of life will be measured by the validated asthma quality of life questionnaire (AQLQ). The AQLQ includes 32 separate responses within 4 domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). Each response option is based on a 7-point scale, where 1 represents maximal impairment and 7 indicates no impairment. Scores for the four domains and overall score are computed as averages of the item scores. The minimal important difference for overall and each domain, has been determined to be a change in score of 0.5 per item.
Dietary Intake Questionnaire
Baseline dietary intake will be assessed by the National Cancer Institute's Diet Health Questionnaire II (DHQ II). It consists of 134 food items and 8 dietary supplement questions. It calculates the Healthy Eating Index (HEI) that is a measure of diet quality. Scores range from 0 to 100. The higher the score the healthier the diet.
Cardiorespiratory Fitness
Cardiorespiratory fitness will be assessed during the EIB test by an integrated metabolic measurement system that will be used for measurement of oxygen consumption. The metabolic cart will be set to produce a 15-second average of the data collected during gas analyses for all tests.
Pulmonary function testing
The outcome will measure the change in the first second of forced expiration (FEV1).
Full Information
NCT ID
NCT03610932
First Posted
June 7, 2018
Last Updated
December 11, 2019
Sponsor
University of Kansas Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03610932
Brief Title
Vitamin C & Exercise Induced Bronchoconstriction (EIB)
Official Title
Vitamin C Supplementation to Improve EIB in College Student-Athletes
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Recruitment
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
May 3, 2019 (Actual)
Study Completion Date
May 3, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this research is to assess the association between diet and pulmonary function during standardized EIB testing. Determine the effect of Vitamin C supplementation on airway inflammatory markers and bronchoconstriction after a standardized EIB test compared to usual diet and placebo control.
Detailed Description
This study will use a double-blind, randomized, cross-over design with subjects serving as their own controls. This study will be conducted over a consecutive five-week period.
All subjects will be asked to discontinue taking their short- and long-acting beta-agonist medication 12 and 24 hours respectively prior to data collection. Also, all subjects will be asked to refrain from caffeine, physical activity, and NSAID use 24 hours prior to testing. In addition all subjects will be asked to abstain from taking any vitamin supplement during the course of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise-induced Bronchospasm
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin C
Arm Type
Experimental
Arm Description
Participants will ingest 3 (500 mg) capsules of Vitamin C each day for 2 weeks.
Arm Title
Placebo
Arm Type
Active Comparator
Arm Description
Participants will ingest a matched capsule for size and color to the Vitamin C supplement.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin C
Intervention Description
Taken as 3 500mg capsules.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Taken as 3 500mg capsules.
Primary Outcome Measure Information:
Title
Change in airway inflammatory biomarkers
Description
Urinary concentrations of cysteine leukotrienes (LTC4-LTE4), prostaglandin (9α,11β-PGF2), and creatinine will be measured.
Time Frame
Change from Baseline to End of Week 5
Secondary Outcome Measure Information:
Title
Change in quality of life: asthma quality of life questionnaire (AQLQ)
Description
Asthma specific quality of life will be measured by the validated asthma quality of life questionnaire (AQLQ). The AQLQ includes 32 separate responses within 4 domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). Each response option is based on a 7-point scale, where 1 represents maximal impairment and 7 indicates no impairment. Scores for the four domains and overall score are computed as averages of the item scores. The minimal important difference for overall and each domain, has been determined to be a change in score of 0.5 per item.
Time Frame
Change from Baseline to End of Week 5
Title
Dietary Intake Questionnaire
Description
Baseline dietary intake will be assessed by the National Cancer Institute's Diet Health Questionnaire II (DHQ II). It consists of 134 food items and 8 dietary supplement questions. It calculates the Healthy Eating Index (HEI) that is a measure of diet quality. Scores range from 0 to 100. The higher the score the healthier the diet.
Time Frame
Change from Baseline to End of Week 5
Title
Cardiorespiratory Fitness
Description
Cardiorespiratory fitness will be assessed during the EIB test by an integrated metabolic measurement system that will be used for measurement of oxygen consumption. The metabolic cart will be set to produce a 15-second average of the data collected during gas analyses for all tests.
Time Frame
Baseline
Title
Pulmonary function testing
Description
The outcome will measure the change in the first second of forced expiration (FEV1).
Time Frame
Change from Baseline to End of Week 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Student or student-athlete who has tested positive for EIB
Able to communicate in English
Exclusion Criteria:
Forced expiratory volume in 1 second (FEV1) < 70% of predicted, cardiac history,
Current respiratory infection
> 10 pack year history of smoking
Pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dave Burnett, PhD, RRT, AE-C
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
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Vitamin C & Exercise Induced Bronchoconstriction (EIB)
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