Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT00420602
Status:
COMPLETED
Last Update Posted:
2018-05-09
First Post:
2007-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
DHA Supplementation in Patients With STGD3
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-12-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-08', 'studyFirstSubmitDate': '2007-01-10', 'studyFirstSubmitQcDate': '2007-01-10', 'lastUpdatePostDateStruct': {'date': '2018-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ERG', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Visual acuity', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Dominantly Inherited Stargardt's Disease (STGD3)"]}, 'descriptionModule': {'briefSummary': 'We have found that biomarkers of long-term elevated dietary intake of omega-3 fatty acids such as DHA and EPA are inversely associated with severity of disease phenotype in STGD3 patients. Therefore, the purpose of this study is to follow STGD3 patients as they supplement their diets with DHA/EPA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '105 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All Moran Eye Center patients with STGD3\n\nExclusion Criteria:\n\n* All others'}, 'identificationModule': {'nctId': 'NCT00420602', 'briefTitle': 'DHA Supplementation in Patients With STGD3', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Clinical Interventions Against Stargardt Macular Dystrophy: DHA Supplementation in Patients With STGD3', 'orgStudyIdInfo': {'id': 'IRB 19676'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single Arm, Open Label', 'description': 'Single Arm, Open Label', 'interventionNames': ['Dietary Supplement: Over the counter DHA/EPA dietary supplementation']}], 'interventions': [{'name': 'Over the counter DHA/EPA dietary supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': '1000 mg/day DHA/EPA', 'armGroupLabels': ['Single Arm, Open Label']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Moran Eye Center, University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Paul S. Bernstein, MD Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Ophthalmology', 'investigatorFullName': 'Paul S. Bernstein', 'investigatorAffiliation': 'University of Utah'}}}}