Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT05545020
Status:
COMPLETED
Last Update Posted:
2024-02-06
First Post:
2022-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trivalent Chromium Treatment for Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057126', 'term': 'Nuclear Receptor Subfamily 4, Group A, Member 2'}], 'ancestors': [{'id': 'D057093', 'term': 'Orphan Nuclear Receptors'}, {'id': 'D004268', 'term': 'DNA-Binding Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D018160', 'term': 'Receptors, Cytoplasmic and Nuclear'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-01-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-04', 'studyFirstSubmitDate': '2022-09-09', 'studyFirstSubmitQcDate': '2022-09-13', 'lastUpdatePostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arthritis scored by DAS28 score', 'timeFrame': 'three months', 'description': 'DAS 28 is a score of arthritis'}, {'measure': 'ESR in mm/hr', 'timeFrame': 'three months', 'description': 'lab measures for disease activity'}, {'measure': 'CRP mg/dL', 'timeFrame': 'three months', 'description': 'lab measures for disease activity'}, {'measure': 'Radiological investigations if required (X-RAY, ultrasound, MRI, bone scan)', 'timeFrame': 'three months', 'description': 'To assess joints and bone'}], 'secondaryOutcomes': [{'measure': 'Serum urea', 'timeFrame': 'three months', 'description': 'A renal function test to exclude trivalent chromium side effects.'}, {'measure': 'serum creatinine', 'timeFrame': 'three months', 'description': 'A renal function test to exclude trivalent chromium side effects.'}, {'measure': 'SGOT', 'timeFrame': 'three months', 'description': 'A liver function test to exclude trivalent chromium side effects.'}, {'measure': 'SGPT', 'timeFrame': 'three months', 'description': 'A liver function test to exclude trivalent chromium side effects.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '35829940', 'type': 'BACKGROUND', 'citation': 'Hassouna SS, Sheta E, Zaki I, Harby SA, Allam EA. Trivalent chromium supplementation ameliorates adjuvant induced rheumatoid arthritis through up-regulation of FOXP3 and decrease in synovial Cathepsin G expression. Inflammopharmacology. 2022 Dec;30(6):2181-2195. doi: 10.1007/s10787-022-01025-8. Epub 2022 Jul 13.'}, {'pmid': '39030450', 'type': 'DERIVED', 'citation': 'Hassouna SS, Abdel-Moniem OM. Trivalent chromium versus baricitinib for rheumatoid arthritis treatment: first phase 2/3 randomized controlled trial, is trivalent chromium the upcoming immune-modulator? Inflammopharmacology. 2024 Oct;32(5):3163-3179. doi: 10.1007/s10787-024-01515-x. Epub 2024 Jul 19.'}]}, 'descriptionModule': {'briefSummary': 'Trivalent chromium has shown good results in abolishing inflammation and had a successful result in treating animal model of rheumatoid arthritis. In addition to that, trivalent chromium lacks many side effects which are related to the already known medications of the disease.\n\nSo this study aims to evaluate the efficacy of trivalent chromium supplementation in rheumatoid arthritis treatment and measuring the outcomes of that in rheumatoid arthritis patients.', 'detailedDescription': 'Rheumatoid arthritis is a debilitating autoimmune disease which is treated by medications that have many side effects. Trivalent chromium, a naturally occurring element with regulatory effects on blood sugar, has shown anti-inflammatory properties in many studies and has shown a good response at alleviation of rheumatoid arthritis in the disease animal model. For these reasons trivalent chromium should be tried in rheumatoid arthritis patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* rheumatoid arthritis\n\nExclusion Criteria:\n\n* other autoimmune diseases'}, 'identificationModule': {'nctId': 'NCT05545020', 'briefTitle': 'Trivalent Chromium Treatment for Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Trivalent Chromium as a Treatment for Rheumatoid Arthritis Patients', 'orgStudyIdInfo': {'id': 'Trivalent chromium treatment'}, 'secondaryIdInfos': [{'id': '040457', 'type': 'REGISTRY', 'domain': 'Ethics committee of Faculty of Medicine, Alexandria university, Egypt'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Trivalent chromium', 'description': 'A dietary supplement already available in market one of its known uses is to control diabetes.', 'interventionNames': ['Drug: Trivalent chromium versus synthetic and/ or biological DMARDs']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Immunesuppressants', 'description': 'Synthetic and/ or biological DMARDs', 'interventionNames': ['Drug: Trivalent chromium versus synthetic and/ or biological DMARDs']}], 'interventions': [{'name': 'Trivalent chromium versus synthetic and/ or biological DMARDs', 'type': 'DRUG', 'otherNames': ['Pure trivalent chromium (not in the form of a compound) and treatments the patients are already taking in comparison'], 'description': 'Supplement and immunesuppressants', 'armGroupLabels': ['Immunesuppressants', 'Trivalent chromium']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Faculty of Medicine, Alexandria University, Egypt', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Internal Medicine department, Rheumatology and Immunology Unit', 'investigatorFullName': 'Sally Saad Saad Hassouna', 'investigatorAffiliation': 'Alexandria University'}}}}