Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2026-01-01 @ 4:25 AM
Study NCT ID:
NCT03610932
Status:
WITHDRAWN
Last Update Posted:
2019-12-13
First Post:
2018-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin C & Exercise Induced Bronchoconstriction (EIB)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001250', 'term': 'Asthma, Exercise-Induced'}], 'ancestors': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D000092202', 'term': 'Exercise-Induced Allergies'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001205', 'term': 'Ascorbic Acid'}], 'ancestors': [{'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Recruitment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-11', 'studyFirstSubmitDate': '2018-06-07', 'studyFirstSubmitQcDate': '2018-07-25', 'lastUpdatePostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in airway inflammatory biomarkers', 'timeFrame': 'Change from Baseline to End of Week 5', 'description': 'Urinary concentrations of cysteine leukotrienes (LTC4-LTE4), prostaglandin (9α,11β-PGF2), and creatinine will be measured.'}], 'secondaryOutcomes': [{'measure': 'Change in quality of life: asthma quality of life questionnaire (AQLQ)', 'timeFrame': 'Change from Baseline to End of Week 5', '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.'}, {'measure': 'Dietary Intake Questionnaire', 'timeFrame': 'Change from Baseline to End of Week 5', '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."}, {'measure': 'Cardiorespiratory Fitness', 'timeFrame': 'Baseline', '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.'}, {'measure': 'Pulmonary function testing', 'timeFrame': 'Change from Baseline to End of Week 5', 'description': 'The outcome will measure the change in the first second of forced expiration (FEV1).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Exercise-induced Bronchospasm']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nAll 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Student or student-athlete who has tested positive for EIB\n* Able to communicate in English\n\nExclusion Criteria:\n\n* Forced expiratory volume in 1 second (FEV1) \\< 70% of predicted, cardiac history,\n* Current respiratory infection\n* \\> 10 pack year history of smoking\n* Pregnancy.'}, 'identificationModule': {'nctId': 'NCT03610932', 'briefTitle': 'Vitamin C & Exercise Induced Bronchoconstriction (EIB)', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Vitamin C Supplementation to Improve EIB in College Student-Athletes', 'orgStudyIdInfo': {'id': 'STUDY00140641'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin C', 'description': 'Participants will ingest 3 (500 mg) capsules of Vitamin C each day for 2 weeks.', 'interventionNames': ['Dietary Supplement: Vitamin C']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will ingest a matched capsule for size and color to the Vitamin C supplement.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Vitamin C', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Taken as 3 500mg capsules.', 'armGroupLabels': ['Vitamin C']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Taken as 3 500mg capsules.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Dave Burnett, PhD, RRT, AE-C', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}