Vitamin C & Exercise Induced Bronchoconstriction (EIB)

NCT03610932 | Withdrawn

• 1 other identifier: STUDY00140641
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Exercise-induced Bronchospasm

Outcome Measures

Primary Outcomes (1)

• Change in airway inflammatory biomarkers

  Urinary concentrations of cysteine leukotrienes (LTC4-LTE4), prostaglandin (9α,11β-PGF2), and creatinine will be measured.

  Change from Baseline to End of Week 5

Secondary Outcomes (4)

• Change in quality of life: asthma quality of life questionnaire (AQLQ)

  Change from Baseline to End of Week 5

• Dietary Intake Questionnaire

  Change from Baseline to End of Week 5

• Cardiorespiratory Fitness

  Baseline

• Pulmonary function testing

  Change from Baseline to End of Week 5

Study Arms (2)

Vitamin C

EXPERIMENTAL

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

Dietary Supplement: Vitamin C

Placebo

ACTIVE COMPARATOR

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

Other: Placebo

Interventions

Vitamin C DIETARY_SUPPLEMENT

Taken as 3 500mg capsules.

Vitamin C

Placebo OTHER

Taken as 3 500mg capsules.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Student or student-athlete who has tested positive for EIB
• Able to communicate in English

You may not qualify if:

• Forced expiratory volume in 1 second (FEV1) \< 70% of predicted, cardiac history,
• Current respiratory infection
• \> 10 pack year history of smoking
• Pregnancy.

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Asthma, Exercise-Induced

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Exercise-Induced Allergies; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Dave Burnett, PhD, RRT, AE-C

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2018
• First Posted: August 1, 2018
• Study Start: July 1, 2018
• Primary Completion: May 3, 2019
• Study Completion: May 3, 2019
• Last Updated: December 13, 2019

Record last verified: 2019-12

Locations

US (1)