Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT06285851
Status:
COMPLETED
Last Update Posted:
2024-03-28
First Post:
2024-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Novel Iron Supplement for Athletes: Phase I
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-09-20', 'releaseDate': '2024-05-27'}], 'estimatedResultsFirstSubmitDate': '2024-05-27'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}, {'id': 'D003967', 'term': 'Diarrhea'}, {'id': 'D003085', 'term': 'Colic'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-26', 'studyFirstSubmitDate': '2024-01-30', 'studyFirstSubmitQcDate': '2024-02-28', 'lastUpdatePostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'GI Symptoms', 'timeFrame': 'Daily for 14 days', 'description': 'Gastrointestinal Symptoms Questionnaire (rating scale 1-7 where 1= the absence of symptoms and 7=severe symptoms)'}, {'measure': 'Gastrointestinal symptoms', 'timeFrame': 'Weekly for 14 days', 'description': 'Patient-Reported Outcomes Measurement Information System (rating scale 0-4 where 0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much)'}], 'secondaryOutcomes': [{'measure': 'Supplement Tolerability and Preferences Questionnaire', 'timeFrame': '14 days', 'description': 'Consumer preferences compared to standard of care (rating scale 0-4, where 0=not at all and 4=very much)'}, {'measure': 'Recovery', 'timeFrame': '14 days', 'description': 'The Recovery-Stress Questionnaire (rating scale 0-6, where 0=never and 6= always)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Constipation', 'Diarrhea', 'Cramp, Abdominal', 'Bleeding Gastric']}, 'referencesModule': {'references': [{'pmid': '40817080', 'type': 'DERIVED', 'citation': 'Shaw KA, Tompkins TA, Abrahamson-Durant B, MacNevin G, Parnell JA, MacInnis MJ, Reimer RA, Shearer J. Exploring tolerance and side effects of an innovative yeast-bound iron supplement: a feasibility trial. Pilot Feasibility Stud. 2025 Aug 15;11(1):110. doi: 10.1186/s40814-025-01690-w.'}]}, 'descriptionModule': {'briefSummary': 'Female endurance athletes are susceptible to iron deficiency and this can impact their exercise performance. This study is a pilot trial to assess the tolerability of a novel iron supplement prior to conducting a clinical trial on the efficacy of the developed novel iron supplement on iron status and performance.', 'detailedDescription': 'Current iron supplements on the market are commonly associated with side effects including gastrointestinal distress, nausea, vomiting, and constipation. As a solution, the investigators have developed a novel delivery system for iron supplementation that overcomes many of these limitations. The goal of this study is to assess the tolerability of the developed supplement and any associated symptoms before conducting a clinical trial on this product. Participants will consume 40mg of elemental iron every second day for 14 days. Participants will complete a daily survey in which they will report feelings of stress and recovery as well as gastrointestinal symptoms. Additionally, participants will complete a more thorough survey of gastrointestinal symptoms at baseline, the mid-point, and the end of the study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cis-gendered female 18-25years old\n* BMI \\<25 kg/m2\n* engaging in moderate to vigorous physical activity for ≥3 hours per week\n\nExclusion Criteria:\n\n* gastrointestinal issues (e.g. Irritable bowel disease/syndrome)\n* chronic illnesses\n* prescription medication (including oral contraceptives)\n* allergies to supplement ingredients\n* iron supplementation in the last 3 months'}, 'identificationModule': {'nctId': 'NCT06285851', 'briefTitle': 'A Novel Iron Supplement for Athletes: Phase I', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'Pilot Study for a Novel Iron-Based Supplement for Athletes', 'orgStudyIdInfo': {'id': '23-0825'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FeSC Cookie', 'description': 'Iron-yeast complex', 'interventionNames': ['Dietary Supplement: FeSC']}], 'interventions': [{'name': 'FeSC', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Supplement', 'armGroupLabels': ['FeSC Cookie']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'overallOfficials': [{'name': 'Jane Shearer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lallemand Bio-Ingredients', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jane Shearer', 'investigatorAffiliation': 'University of Calgary'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-05-27', 'type': 'RELEASE'}, {'date': '2024-09-20', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Jane Shearer, Principal Investigator, University of Calgary'}}}}