Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2026-04-14 @ 1:41 PM
Study NCT ID:
NCT02463318
Status:
COMPLETED
Last Update Posted:
2017-05-02
First Post:
2015-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Melatonin on Gene Expression and Activity of the Sirt1 and Its Target Genes Catalase and MnSOD in Multiple Sclerosis Patients and Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'D008550', 'term': 'Melatonin'}, {'id': 'D006861', 'term': 'Hydrogen Peroxide'}], 'ancestors': [{'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010545', 'term': 'Peroxides'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017382', 'term': 'Reactive Oxygen Species'}, {'id': 'D005609', 'term': 'Free Radicals'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-30', 'studyFirstSubmitDate': '2015-06-02', 'studyFirstSubmitQcDate': '2015-06-02', 'lastUpdatePostDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative gene expression by real-time PCR (polymerase chain reaction)', 'timeFrame': 'Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2'}], 'secondaryOutcomes': [{'measure': 'MnSOD enzyme activity assay', 'timeFrame': 'Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2'}, {'measure': 'Catalse enzyme activity assay', 'timeFrame': 'Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2'}, {'measure': 'SIRT1 enzyme activity assay', 'timeFrame': 'Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Multiple sclerosis', 'SIRT1', 'MnSOD', 'Catalase', 'Oxidative stress', 'Antioxidant enzyme'], 'conditions': ['Multiple Sclerosis', 'Oxidative Stress']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the gene expression and activity of SIRT1, and forkhead box O3 pathway by means of investigating target genes MnSOD and catalase in multiple sclerosis and healthy subjects. Also, we investigate the effect of melatonin on interaction between SIRT1 activity and target genes MnSOD and catalase in multiple sclerosis and healthy subject .Additionally, we evaluate effect the probable effect of melatonin treatment on gene expression and activity of above-mentioned genes in peripheral blood mononuclear cells of healthy subjects-treated with H2O2.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\npatients with relapsing-remitting multiple sclerosis. The diagnosis of MS was based on the McDonald criteria . All patients were newly diagnosed cases with an Expanded Disability Status Scale (EDSS) score ≤ 6 and had never received immunomodulatory and immunosuppressive drugs.\n\n\\-\n\nExclusion Criteria:\n\n* The exclusion criteria were as follows: 1) treated with antioxidant supplements, anti-inflammatory drugs, and vitamins in the previous 6 months; 2) had a history of acute or chronic infection, malignancy, diabetes (type I and II), and any clinically significant systemic disease; 3) was currently pregnant or lactating; 4) was currently smoking; 5) used contraceptive medication during the previous 6 months.'}, 'identificationModule': {'nctId': 'NCT02463318', 'briefTitle': 'The Effect of Melatonin on Gene Expression and Activity of the Sirt1 and Its Target Genes Catalase and MnSOD in Multiple Sclerosis Patients and Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Tehran University of Medical Sciences'}, 'orgStudyIdInfo': {'id': '91-01-30-17019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multiple slerosis', 'description': 'Melatonin,,one millimolar,one micromolar,one nanomolar, 12 hr treatment.', 'interventionNames': ['Drug: Melatonin']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy subjects', 'description': 'Melatonin,one millimolar,one micromolar,one nanomolar, 12 hr treatment. hydrogen peroxide, 250 micromollar,2 hr treatment', 'interventionNames': ['Drug: Melatonin', 'Other: Hydrogen peroxide']}], 'interventions': [{'name': 'Melatonin', 'type': 'DRUG', 'otherNames': ['N-acetyl-5-methoxy tryptamine'], 'description': 'Melatonin is used for healthy subjects and multiple sclerosis patients', 'armGroupLabels': ['Healthy subjects', 'Multiple slerosis']}, {'name': 'Hydrogen peroxide', 'type': 'OTHER', 'description': 'Hydrogen peroxide is only used for healthy subjects', 'armGroupLabels': ['Healthy subjects']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'country': 'Iran', 'facility': 'Solaleh Emamgholipour', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Mohammad Ali Sahraian, Neurologist', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tehran University of Medical Sciences'}, {'name': 'Solaleh Emamgholipour, PhD Student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tehran University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tehran University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}