Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT03582267
Status:
COMPLETED
Last Update Posted:
2019-09-13
First Post:
2018-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Docosahexaenoic Acid Supplementation on Biomarkers of Concussion Over the Course of a Year in Canadian National Rugby Players
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006259', 'term': 'Craniocerebral Trauma'}], 'ancestors': [{'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004281', 'term': 'Docosahexaenoic Acids'}], 'ancestors': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-12', 'studyFirstSubmitDate': '2018-06-27', 'studyFirstSubmitQcDate': '2018-07-09', 'lastUpdatePostDateStruct': {'date': '2019-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood concentration of neurofilament light protein', 'timeFrame': '12 times throughout course of 1 year', 'description': 'Concentrations of neuronally derived proteins measured in blood'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Head Trauma']}, 'descriptionModule': {'briefSummary': "Nutrition interventions may present a safe and relatively risk free intervention for protection against subconcussive impacts. Docosahexaenoic acid (DHA, 22:6n-3) is the principal Omega 3 polyunsaturated fatty acid in the brain, playing an integral role in the brain's development and structural integrity. The goal of this study is to determine if supplementation with DHA attenuates blood biomarkers of repetitive head trauma linked to sub-concussive impacts sustained in rugby participation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Canadian national rugby athletes on 7s and 15s teams\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03582267', 'briefTitle': 'The Effect of Docosahexaenoic Acid Supplementation on Biomarkers of Concussion Over the Course of a Year in Canadian National Rugby Players', 'organization': {'class': 'OTHER', 'fullName': 'Texas Christian University'}, 'officialTitle': 'The Effect of Docosahexaenoic Acid Supplementation on Biomarkers of Concussion Over the Course of a Year in Canadian National Rugby Players', 'orgStudyIdInfo': {'id': '1706-066-1706'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dietary Supplement', 'description': 'Docosahexaenoic Acid (DHA)', 'interventionNames': ['Dietary Supplement: Docosahexaenoic Acid (DHA)']}, {'type': 'NO_INTERVENTION', 'label': 'No Intervention', 'description': 'No Docosahexaenoic Acid supplementation'}], 'interventions': [{'name': 'Docosahexaenoic Acid (DHA)', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Brain Armor DHA Liquid Concentrate'], 'description': 'Daily administration of docosahexaenoic Acid (DHA). 2 grams of DHA liquid concentrate administered per day throughout trial period.', 'armGroupLabels': ['Dietary Supplement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76129', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Christian Universti', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Texas Christian University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jonathan Oliver', 'investigatorAffiliation': 'Texas Christian University'}}}}