Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT06033105
Status:
COMPLETED
Last Update Posted:
2024-11-20
First Post:
2023-09-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vitamin D Deficiency As a Risk Factor for the Development and Malignant Transformation of Oral Lichen Planus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017676', 'term': 'Lichen Planus, Oral'}, {'id': 'D014808', 'term': 'Vitamin D Deficiency'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D008010', 'term': 'Lichen Planus'}, {'id': 'D017512', 'term': 'Lichenoid Eruptions'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004797', 'term': 'Enzyme-Linked Immunosorbent Assay'}], 'ancestors': [{'id': 'D007124', 'term': 'Immunoenzyme Techniques'}, {'id': 'D007118', 'term': 'Immunoassay'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007163', 'term': 'Immunosorbent Techniques'}, {'id': 'D007150', 'term': 'Immunohistochemistry'}, {'id': 'D015336', 'term': 'Molecular Probe Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-17', 'studyFirstSubmitDate': '2023-09-02', 'studyFirstSubmitQcDate': '2023-09-08', 'lastUpdatePostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum vitamin D level in OLP', 'timeFrame': '1 month', 'description': 'measured by ELISA'}], 'secondaryOutcomes': [{'measure': 'serum vitamin D level in correlation with sex, dietary habits and sun exposure.', 'timeFrame': '1 month', 'description': 'Questionnaire, measured in proportions'}, {'measure': 'serum vitamin D level in correlation with socioeconomic status', 'timeFrame': '1 month', 'description': "Kuppuswamy's socioeconomic status scale"}, {'measure': 'serum vitamin D level in correlation with Psychological factors', 'timeFrame': '1 month', 'description': 'Depression Anxiety and Stress Scale 21 (DASS-21)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oral Lichen Planus', 'Vitamin D Deficiency']}, 'descriptionModule': {'briefSummary': 'To examine how a lack of vitamin D may increase the risk of developing oral lichen planus and its malignant progression while accounting for sex, food habits, sunlight, socioeconomic level, and psychological variables.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients presenting with a clinical picture and histological findings that confirm the diagnosis of OLP (Group A) and age, sex, and dietary habits matched healthy controls (Group B).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (Group A) patients presenting with a clinical picture and histological findings that confirm the diagnosis of OLP\n* (Group B) age, sex, and dietary habits matched healthy controls.\n\nExclusion Criteria:\n\n* (1) subjects who have been receiving any kind of VD supplements, multivitamins, or any drug that may affect VD measurements\n* (2) patients with suspected restoration-related or smokeless tobacco-related lesions.\n* (3) patients with any systemic medical condition or pregnant females.\n* (4) patients with VD toxicity (VD≥100 ng/ml).'}, 'identificationModule': {'nctId': 'NCT06033105', 'briefTitle': 'Vitamin D Deficiency As a Risk Factor for the Development and Malignant Transformation of Oral Lichen Planus', 'organization': {'class': 'OTHER', 'fullName': 'Fayoum University'}, 'officialTitle': 'Vitamin D Deficiency As a Risk Factor for the Development and Malignant Transformation of Oral Lichen Planus: a Case-control Study', 'orgStudyIdInfo': {'id': '2191982'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A', 'description': '35 OLP patients', 'interventionNames': ['Device: ELISA']}, {'label': 'Group B', 'description': '35 healthy controls.', 'interventionNames': ['Device: ELISA']}], 'interventions': [{'name': 'ELISA', 'type': 'DEVICE', 'description': "Enzyme-linked immunosorbent assay (ELISA) was used following manufacturer's instructions. This test uses a competitive ELISA-based technique that was designed to quantitatively determine the concentration of 1,25-dihydroxyvitamin D3/D2 in human serum.", 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Fayyum', 'country': 'Egypt', 'facility': 'Fayoum University', 'geoPoint': {'lat': 29.30995, 'lon': 30.8418}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Upon Request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fayoum University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Salsabeel A Afifi, PhD', 'investigatorAffiliation': 'Fayoum University'}}}}