Vitamin C & Exercise Induced Bronchoconstriction (EIB)

Exercise-induced Bronchospasm Clinical Trial

Official title:

Vitamin C Supplementation to Improve EIB in College Student-Athletes

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03610932
• Other study ID #: STUDY00140641
• Status: Withdrawn
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: May 3, 2019

Study information

• Verified date: December 2019
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 3, 2019
• Est. primary completion date: May 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma, Exercise-Induced
• Bronchial Spasm
• Exercise-induced Bronchospasm

Intervention

Dietary Supplement:
• Vitamin C
Taken as 3 500mg capsules.

Other:
• Placebo
Taken as 3 500mg capsules.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in airway inflammatory biomarkers	Urinary concentrations of cysteine leukotrienes (LTC4-LTE4), prostaglandin (9a,11ß-PGF2), and creatinine will be measured.	Change from Baseline to End of Week 5
Secondary	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.	Change from Baseline to End of Week 5
Secondary	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.	Change from Baseline to End of Week 5
Secondary	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.	Baseline
Secondary	Pulmonary function testing	The outcome will measure the change in the first second of forced expiration (FEV1).	Change from Baseline to End of Week 5