Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-30 @ 5:21 AM
Study NCT ID:
NCT01705457
Status:
UNKNOWN
Last Update Posted:
2012-10-12
First Post:
2012-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Vitamin A on RAR Gene Expression in Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}, {'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C014794', 'term': 'retinol palmitate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2013-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-10-11', 'studyFirstSubmitDate': '2012-10-09', 'studyFirstSubmitQcDate': '2012-10-11', 'lastUpdatePostDateStruct': {'date': '2012-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gene expression of RAR(Relative quantification)', 'timeFrame': 'Change from baseline at 6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['multiple sclerosis', 'Vitamin A', 'retinoic acid receptor', 'retinoic x receptor'], 'conditions': ['Relapsing Remitting Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'The aim of this study is the comparison between the effects of supplementation with 25000 IU preformed vitamin A (retinyl palmitate)on retinoic acid receptor and retinoic x receptor expression.', 'detailedDescription': 'Multiple Sclerosis (MS) is a chronic inflammatory disease where Th1 like responses from myelin-specific CD4+ T cells, as secretion of pro-inflammatory IFNγ, are believed to play a major role in the pathogenesis. The myelin-specific T cells that mediate tissue destruction in MS are believed to become activated outside the central nervous system (CNS) in lymphoid tissue and when they cross the blood brain barrier they will re-encounter their antigen. Immune deviation is the redirection of the immune response from most often Th1 like responses to Th2 like responses, even though the opposite can also occur. Vitamin A or Vitamin A-like analogs known as retinoids, are potent hormonal modifiers of type 1 or type 2 responses but a definitive description of their mechanism(s) of action is lacking. High level dietary vitamin A enhances Th2 cytokine production and IgA responses, and is likely to decrease Th1 cytokine production. Retinoic acid(RA) inhibits IL12 production in activated macrophages, and RA pretreatment of macrophages reduces IFNγ production and increases IL4 production in antigen primed CD4 T cells. Supplemental treatment with vitamin A or RA decreases IFNγ and increases IL5, IL10, and IL4 production by increase of retinoic acid receptor and retinoic x receptor .\n\nRecord Verification Date: August 2011'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have used interferon beta in last 3 months.\n* Patients with 0-5 EDSS\n\nExclusion Criteria:\n\n* Patients who have diseases which affect on Th1/Th2 balance such as asthma, active viral infections, and autoimmune diseases, OR\n* Patients who have allergy to vitamin A compounds, OR\n* Patients who have used vitamin supplements in last 3 months.'}, 'identificationModule': {'nctId': 'NCT01705457', 'acronym': 'RAR', 'briefTitle': 'Impact of Vitamin A on RAR Gene Expression in Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Tehran University of Medical Sciences'}, 'officialTitle': 'Impact of Vitamin A Supplementation on RAR Gene Expression in PBMC Cells in Multiple Sclerotic Patients', 'orgStudyIdInfo': {'id': '91-03-161-19476'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'with Multiple Sclerosis, vitamin A', 'description': 'Patients with Multiple Sclerosis confirmed Relapsing Remitting Type', 'interventionNames': ['Drug: Dietary Supplement: vitamin A']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'with multiple sclerosis,placebo', 'description': 'Patients with Multiple Sclerosis confirmed Relapsing Remitting Type', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Dietary Supplement: vitamin A', 'type': 'DRUG', 'otherNames': ['Retinyl palmitate'], 'description': '25000 IU/day vitamin A for 6 months\n\n1 Cap/Day\n\n1 cap placebo/day for 6 month', 'armGroupLabels': ['with Multiple Sclerosis, vitamin A']}, {'name': 'placebo', 'type': 'DRUG', 'armGroupLabels': ['with multiple sclerosis,placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'country': 'Iran', 'facility': 'Tehran University of Medical Sciences,', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Ali Akbar saboor Yaraghi, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Tehran University of Medical Sciences'}, {'name': 'Sama Bitarafan, MD, PhD student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tehran University of Medical Siences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tehran University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}