Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT05907850
Status:
COMPLETED
Last Update Posted:
2025-04-03
First Post:
2023-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Riboflavin in Mitigating Muscle Soreness in Ultra-marathon Athletes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063806', 'term': 'Myalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D059352', 'term': 'Musculoskeletal Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012256', 'term': 'Riboflavin'}], 'ancestors': [{'id': 'D005415', 'term': 'Flavins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Subjects will be masked to which intervention they receive, active study drug or placebo.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A phase I randomized, 2 arm single blinded feasibility study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-31', 'studyFirstSubmitDate': '2023-06-08', 'studyFirstSubmitQcDate': '2023-06-08', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle soreness measure for long stage of the ultramarathon', 'timeFrame': 'Baseline to 6 days', 'description': 'Change in muscle soreness at completion of the long stage (80+ kilometers) of the ultramarathon. Muscle soreness the day following long stage completion. Muscle soreness will be measured using a Likert scale rated from 0 to 10 where 0 indicates no soreness and 10 indicates unbearable pain.'}], 'secondaryOutcomes': [{'measure': 'Muscle soreness measure post-race', 'timeFrame': 'Day 7', 'description': 'Muscle soreness the day following long stage completion. Muscle soreness the day following long stage completion. Muscle soreness will be measured using a Likert scale rated from 0 to 10 where 0 indicates no soreness and 10 indicates unbearable pain.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Delayed onset muscle soreness', 'Ultramarathon'], 'conditions': ['Muscle Soreness']}, 'descriptionModule': {'briefSummary': 'The aim of this project is to investigate the effects of riboflavin, also known as vitamin B2, on preventing delayed onset muscle soreness (DOMS) in ultramarathon athletes through a randomized placebo-controlled study.', 'detailedDescription': 'The riboflavin 100 mg capsules will be self-dosed by the participant, one capsule prior to the long stage of the race followed by a second dose at the end of the long stage. Historically, long-stage finish times have ranged between 8 and 24 hours. The placebo will also be dosed as one capsule on the morning of the long stage, prior to the race start, and one capsule at the end of the long stage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, aged 18 or over\n4. In good general health as evidenced by readiness to participate in an ultramarathon\n5. Ability to take oral medication and be willing to adhere to the study regimen\n6. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening.\n\nExclusion Criteria:\n\n1. Unable to read or understand English\n2. Under 18 years of age\n3. Pregnancy or lactation\n4. Known allergic reactions to components of the investigational drugs'}, 'identificationModule': {'nctId': 'NCT05907850', 'briefTitle': 'Effects of Riboflavin in Mitigating Muscle Soreness in Ultra-marathon Athletes', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center at San Antonio'}, 'officialTitle': 'A Randomized Placebo-controlled Trial Investigating the Effects of Riboflavin in Mitigating Muscle Soreness in Ultra-marathon Athletes', 'orgStudyIdInfo': {'id': 'HSC20230413H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Riboflavin Group', 'description': 'Riboflavin 100mg will be self administered by participants, one capsules prior to the long stage of the race followed by a second dose at the completion of the long stage.', 'interventionNames': ['Drug: Riboflavin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo/Control Group', 'description': 'Placebo will be self administered by participants, one capsule prior to the long stage of the race followed by a second dose at the completion of the long stage.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Riboflavin', 'type': 'DRUG', 'otherNames': ['Riboflavin 100mg capsules'], 'description': 'Commercially available source of riboflavin capsules', 'armGroupLabels': ['Riboflavin Group']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Placebo capsule'], 'description': 'Placebo capsule compounded to be similar in appearance to the active intervention', 'armGroupLabels': ['Placebo/Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Steven Moore, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Health Science Center San Antonio'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Steven Moore', 'class': 'OTHER'}, 'collaborators': [{'name': 'Racing the Planet', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Steven Moore', 'investigatorAffiliation': 'The University of Texas Health Science Center at San Antonio'}}}}