Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 1:19 AM
Study NCT ID:
NCT06877494
Status:
COMPLETED
Last Update Posted:
2025-03-14
First Post:
2025-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
the Effects of Fish Oil Supplements on Choroidal Thickness and Blood Flow Perfusion in Children and Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005395', 'term': 'Fish Oils'}], 'ancestors': [{'id': 'D009821', 'term': 'Oils'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2025-03-11', 'studyFirstSubmitQcDate': '2025-03-11', 'lastUpdatePostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Axial length', 'timeFrame': '15±2 days, 30±2 days, and 90±2 days', 'description': 'the change of axial length'}], 'secondaryOutcomes': [{'measure': 'change in equivalent spherical', 'timeFrame': '15±2 days, 30±2 days, and 90±2 days', 'description': 'change in equivalent spherical in both eyes'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fish Oils']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to test the effect of fish oil supplement in terms of vision in children and adolescents. The main question it aims to answer is:\n\nthe differences in changes of choroidal thickness, choroidal blood flow, axial length, and visual acuity between the intervention group and the control group Participants will take the fish oil supplement. a baseline examination will be conducted, followed by follow-up visits at 15, 30, and 90 days after the start of the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age range: 6-9 years old, gender unspecified;\n2. Equivalent spherical power after unilateral cycloplegic eye ranging from 0.75D to -0.5D, with astigmatism not exceeding 1.5D;\n3. Best corrected visual acuity of at least 1.0;\n4. Ability to sign an informed consent form with the presence and understanding of a parent or guardian.\n\nExclusion Criteria:\n\n1. Allergy or intolerance to ω-3 PUFAs or cycloplegics;\n2. Strabismus, history of eye surgery (including strabismus correction surgery), other eye diseases, or systemic diseases;\n3. Currently using myopia prevention measures.'}, 'identificationModule': {'nctId': 'NCT06877494', 'acronym': 'FOS', 'briefTitle': 'the Effects of Fish Oil Supplements on Choroidal Thickness and Blood Flow Perfusion in Children and Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Eye Disease Prevention and Treatment Center'}, 'officialTitle': 'Exploratory Study on the Effects of Fish Oil Supplements on Choroidal Thickness and Blood Flow Perfusion in Children and Adolescents', 'orgStudyIdInfo': {'id': 'YFZXYDK20240115'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'no-treatment control group', 'description': 'No intervention measures are applied'}, {'type': 'EXPERIMENTAL', 'label': 'fish oil supplement group', 'description': 'Twice a day, with one dose of DHA 300mg: EPA 60mg, for a continuous intervention of 90 days', 'interventionNames': ['Dietary Supplement: fish oil']}], 'interventions': [{'name': 'fish oil', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Twice a day, with one dose of DHA 300mg: EPA 60mg, for a continuous intervention of 90 days', 'armGroupLabels': ['fish oil supplement group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20041', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Eye Disease Prevention and Treatment Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Eye Disease Prevention and Treatment Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}