Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2026-02-23 @ 6:25 AM
Study NCT ID:
NCT01465893
Status:
UNKNOWN
Last Update Posted:
2011-11-22
First Post:
2011-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Vitamin D on Retinal Changes in Patient With Optic Neuritis by Optic Coherence Tomography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009902', 'term': 'Optic Neuritis'}], 'ancestors': [{'id': 'D009901', 'term': 'Optic Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014807', 'term': 'Vitamin D'}], 'ancestors': [{'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-11-21', 'studyFirstSubmitDate': '2011-10-28', 'studyFirstSubmitQcDate': '2011-11-04', 'lastUpdatePostDateStruct': {'date': '2011-11-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'measurement Retinal nerve fiber layer (RNFL) thickness by OCT', 'timeFrame': '10-32 days after optic neuritis'}], 'secondaryOutcomes': [{'measure': 'measurement RNFL thickness by OCT', 'timeFrame': '6 months after optic neuritis'}]}, 'conditionsModule': {'keywords': ['vitamin d'], 'conditions': ['Optic Neuritis']}, 'referencesModule': {'references': [{'pmid': '26109993', 'type': 'DERIVED', 'citation': 'Salari M, Janghorbani M, Etemadifar M, Dehghani A, Razmjoo H, Naderian G. Effects of vitamin D on retinal nerve fiber layer in vitamin D deficient patients with optic neuritis: Preliminary findings of a randomized, placebo-controlled trial. J Res Med Sci. 2015 Apr;20(4):372-8.'}]}, 'descriptionModule': {'briefSummary': 'This study examines the effect of vitamin D on Retinal changes in patient with optic Neuritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 15-50 years\n* no history of demyelinative events\n* level of vitamin d below 20 ng/ml\n* no pass 10-32 day from starting symptom\n\nExclusion Criteria:\n\n* using vitamin D supplement'}, 'identificationModule': {'nctId': 'NCT01465893', 'briefTitle': 'Effect of Vitamin D on Retinal Changes in Patient With Optic Neuritis by Optic Coherence Tomography', 'organization': {'class': 'OTHER', 'fullName': 'Isfahan University of Medical Sciences'}, 'officialTitle': 'The Investigation Effect of Vitamin D on Retinal Changes in Patient With Optic Neuritis by Optic Coherence Tomography', 'orgStudyIdInfo': {'id': 'isfahan medical university'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'vitamin D', 'description': 'vitamin d 50000/w', 'interventionNames': ['Drug: Vitamin D']}, {'type': 'SHAM_COMPARATOR', 'label': 'control', 'description': 'follow up', 'interventionNames': ['Drug: Vitamin D withheld']}], 'interventions': [{'name': 'Vitamin D', 'type': 'DRUG', 'description': 'vitamin D ,50000 unit /week', 'armGroupLabels': ['vitamin D']}, {'name': 'Vitamin D withheld', 'type': 'DRUG', 'description': 'do not receive anything', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'mehri salari, neurology resident', 'role': 'CONTACT', 'email': 'mehri.salari@yahoo.com', 'phone': '09124972186'}, {'name': 'masoud etemadifar, neurology proffesor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'mehri salari, neurology resident', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Isfahan Medical University', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isfahan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'neurology proffesor', 'investigatorFullName': 'Masoud Etemadifar', 'investigatorAffiliation': 'Isfahan University of Medical Sciences'}}}}