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Vitamin C & Exercise Induced Bronchoconstriction (EIB)

NCT ID: NCT03610932

Last Updated: 2019-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2019-05-03

Brief Summary

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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

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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.

Conditions

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Exercise-induced Bronchospasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Vitamin C

Participants will ingest 3 (500 mg) capsules of Vitamin C each day for 2 weeks.

Group Type EXPERIMENTAL

Vitamin C

Intervention Type DIETARY_SUPPLEMENT

Taken as 3 500mg capsules.

Placebo

Participants will ingest a matched capsule for size and color to the Vitamin C supplement.

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type OTHER

Taken as 3 500mg capsules.

Interventions

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Vitamin C

Taken as 3 500mg capsules.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Taken as 3 500mg capsules.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dave Burnett, PhD, RRT, AE-C

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00140641

Identifier Type: -

Identifier Source: org_study_id