Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2026-03-04 @ 10:12 PM
Study NCT ID:
NCT04529668
Status:
UNKNOWN
Last Update Posted:
2020-08-31
First Post:
2020-08-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Vitamin d Deficiency in Chronic Rhinosinusitis With Nasal Polyposis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D009298', 'term': 'Nasal Polyps'}], 'ancestors': [{'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'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'all will be masked'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-10-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-27', 'studyFirstSubmitDate': '2020-08-25', 'studyFirstSubmitQcDate': '2020-08-25', 'lastUpdatePostDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'patient complaint', 'timeFrame': '6 weeks', 'description': 'by SNOT-22 , Sino-nasal Outcome Test , completion of the SNOT-22 prior to and following Vitamin D supplementation . Each subject completed the SNOT-22 during a clinic visit by answering all questions based on a 0-5 scale, where 0 defines no problems with the given symptom and 5 defines maximal problems'}, {'measure': 'examintaion', 'timeFrame': '6 weeks', 'description': 'Lund \\& Kennedy endoscopic appearance score, examination will be done before and after vitamin D supplementation , with 0 means absent finding and 2 means worst finding'}, {'measure': 'histopathology', 'timeFrame': '6 weeks', 'description': 'immunohistochemitsry for fibroblast growth factor'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['VITAMIN D DEFICIENCY, CHRONIC RHINOSINUSITIS WITH NASAL POLYPOSIS'], 'conditions': ['Vitamin D Deficiency, Nasal Polyposis']}, 'referencesModule': {'references': [{'pmid': '22469599', 'type': 'RESULT', 'citation': 'Fokkens WJ, Lund VJ, Mullol J, Bachert C, Alobid I, Baroody F, Cohen N, Cervin A, Douglas R, Gevaert P, Georgalas C, Goossens H, Harvey R, Hellings P, Hopkins C, Jones N, Joos G, Kalogjera L, Kern B, Kowalski M, Price D, Riechelmann H, Schlosser R, Senior B, Thomas M, Toskala E, Voegels R, Wang de Y, Wormald PJ. EPOS 2012: European position paper on rhinosinusitis and nasal polyps 2012. A summary for otorhinolaryngologists. Rhinology. 2012 Mar;50(1):1-12. doi: 10.4193/Rhino12.000.'}]}, 'descriptionModule': {'briefSummary': "Aim of the work\n\n1. To determine if chronic rhinosinusitis with nasal polyps' (CRSwNP) populations are vitamin D deficient.\n2. To determine the possible anti-inflammatory effect of vitamin D supplementation (clinically \\& histologically). \\& investigate its relation to immunohistochemical tissue expression of basic fibroblast growth factor", 'detailedDescription': "Patients \\& methods\n\nStudy groups:\n\nFifty patients with the clinical diagnosis of chronic rhinosinusitis with nasal Polyposis (CRSwNP) resistant to medical treatment at Otorhinolaryngology outpatient clinic, Ain Shams University hospitals. Group I : twenty five patients will receive vitamin D supplementation, while group II won't receive vitamin D supplementation.\n\nInclusion criteria:\n\nPatients (18-60) years of age with clinical diagnosis of chronic rhinosinusitis with nasal Polyposis (CRSwNP) resistant to medical treatment at Otorhinolaryngology outpatient clinic, Ain Shams University hospital.\n\nBoth groups (I \\& II) will be subjected to venous blood sampling and 25(OH) vitamin D level measurement \\& will be subjected to:\n\n1. Careful history taking.\n2. Complete ENT examination and endoscopic evaluation of the nose.\n3. CT scan paranasal sinuses coronal and axial view to evaluate the affected sinuses.\n4. Vitamin D3 serum level (before Vitamin D3 supplementation).\n5. Biopsy from nasal polyps \\& immunohistochemical assessment (before Vitamin D3 supplementation).\n6. Vitamin D3 supplementation 50000 IU/weekly for 6 weeks.\n7. Vitamin D3 serum level (after Vitamin D3 supplementation).\n8. Biopsy from nasal polyps \\& immunohistochemical assessment (after Vitamin D3 supplementation).\n\nExclusion criteria:\n\n* Pregnant and lactating females.\n* Patients taking multivitamins containing vitamin D for at least six months.\n* Immune deficiency or suppression.\n* Ciliary motility disorders.\n* Wegner's granulomatosis and other granulomatous diseases.\n* Sino-nasal malignancy.\n\n 1. History:\n\n 1. Personal history: name, age, sex, occupation and environment (smoking, exposure to irritants).\n 2. Complaint and history of present illness: analysis of the patient's chief complaints with special emphasis on CRS symptoms.\n 3. Medical history: Previous medical treatment for CRS (antibiotics, topical and systemic corticosteroids, etc...) or for any other disease (allergy, hypertension, asthma, GERD, etc...) including questions about the dose and duration of treatment and the achieved results. It included also past history of surgery.\n 4. Family history: History of allergy, asthma, polyposis, migraine, genetic diseases, etc….\n 2. Examination:\n\n 1. General examination: it will be done for all patients as a routine.\n 2. Local examination (complete ENT examination): Oral, laryngeal and ear examination will be done to exclude other ENT disease and then careful nasal examination will be done.\n 3. Endoscopic examination: Diagnostic nasal endoscopy will be done for all patients.\n 3. Investigations:\n\n A- CT scans will be done (in coronal, axial planes) for all patients with chronic rhinosinusitis with nasal Polyposis (CRSwNP).\n\n B- 25-OH Vitamin D serum level: (before \\& after vitamin D supplementation)\n 4. Biopsy from nasal polyps :\n\n Tissue samples will be taken from the nasal polyps of all patients with chronic rhinosinusitis with nasal Polyposis (CRSwNP) at the start of the study (before VD therapy) under local anesthesia at the outpatient clinic for histological (epithelium, basal lamina, lamina propria, cells, blood vessels) \\& immunohistochemical (basic fibroblast growth factors) examination.\n 5. Vitamin D3 supplementation:\n\n Vitamin D3 (cholecalciferol) will be given to the study group Ia orally 50000 IU weekly for 6 weeks. In addition to local nasal steroids \\& saline nasal wash. All patients will be monitored by serum calcium level. While group Ib will not be given vitamin D supplementation.\n 6. Biopsy from nasal polyps :\n\nTissue samples will be taken from the nasal polyps of all patients with chronic rhinosinusitis with nasal Polyposis (CRSwNP) after vitamin D supplementation for immunohistochemical assessment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients (18-60) years of age with clinical diagnosis of chronic rhinosinusitis with nasal Polyposis (CRSwNP) at Otorhinolaryngology outpatient clinic, Ain Shams University hospital.\n\nExclusion Criteria:\n\n* • Pregnant and lactating females.\n\n * Patients taking multivitamins containing vitamin D for at least six months.\n * Immune deficiency or suppression.\n * Ciliary motility disorders.\n * Wegner's granulomatosis and other granulomatous diseases.\n * Sino-nasal malignancy."}, 'identificationModule': {'nctId': 'NCT04529668', 'briefTitle': 'Effect of Vitamin d Deficiency in Chronic Rhinosinusitis With Nasal Polyposis', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Effect of Vitamin d Deficiency in Chronic Rhinosinusitis With Nasal Polyposis: Clinical, Laboratory & Immunohistochemical Study', 'orgStudyIdInfo': {'id': 'FMASUMD241/2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group I', 'description': 'twenty-five patients with the clinical diagnosis of chronic rhinosinusitis with nasal Polyposis will receive vitamin D supplementation', 'interventionNames': ['Drug: vitamin D supplementation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group II', 'description': 'twenty-five patients with the clinical diagnosis of chronic rhinosinusitis with nasal Polyposis will NOT receive vitamin D supplementation', 'interventionNames': ['Drug: usual therapy for nasal polyposis']}], 'interventions': [{'name': 'vitamin D supplementation', 'type': 'DRUG', 'description': 'vitamin D supplementation', 'armGroupLabels': ['group I']}, {'name': 'usual therapy for nasal polyposis', 'type': 'DRUG', 'description': 'steroids ( systemic and local )', 'armGroupLabels': ['group II']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Fatma S Ebeid, MD', 'role': 'CONTACT', 'email': 'dr.fatma_ebeid@yahoo.com', 'phone': '+20109556 9596'}], 'facility': 'Ain shams Univesrity', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Fatma S Ebeid, MD', 'role': 'CONTACT', 'email': 'dr.fatma_ebeid@yahoo.com', 'phone': '+20109556 9596'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Mohammad Salah Mohammad Mahmoud', 'investigatorAffiliation': 'Ain Shams University'}}}}