Ignite Creation Date:
2025-12-24 @ 12:19 PM
Ignite Modification Date:
2026-04-22 @ 12:45 PM
Study NCT ID:
NCT02668861
Status:
UNKNOWN
Last Update Posted:
2016-12-06
First Post:
2016-01-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Oral Vitamin D3 on Chronic Rhinosinusitis Treatment in Adults With Lower Vitamin D Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D019819', 'term': 'Budesonide'}], 'ancestors': [{'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-03', 'studyFirstSubmitDate': '2016-01-27', 'studyFirstSubmitQcDate': '2016-01-27', 'lastUpdatePostDateStruct': {'date': '2016-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS evaluation of usual symptoms in patients with CRSwNP', 'timeFrame': 'at 8 weeks after first drug intake', 'description': 'The evaluated symptoms were nasal obstruction, anterior nasal discharge and post-nasal drip, smelling reduction and facial pain'}, {'measure': 'Questionnaire：SNOT-20 evaluates the quality of Life', 'timeFrame': 'at 8 weeks after first drug intake'}, {'measure': 'Change of Lund-Kennedy scores', 'timeFrame': 'at 8 weeks after first drug intake'}], 'secondaryOutcomes': [{'measure': 'Inflammatory mediators in serum', 'timeFrame': '8 weeks'}, {'measure': 'Histologic analysis of nasal mucosa', 'timeFrame': '8 weeks'}]}, 'conditionsModule': {'conditions': ['Chronic Rhinosinusitis With Nasal Polyps']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to test the clinical efficacy of oral Vitamin D3 on Wound Healing in patients with Chronic Rhinosinusitis With Nasal Polyposis and Lower Vitamin D Levels After Endonasal Endoscopic Sinus Surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Clinical diagnosis of Chronic Rhinosinusitis with nasal polyps 2. Be 18-60 years old of Chinese people and of either sex，the Han nationality 3. Vitamin D level of less than 30 ng/ml\n\nExclusion Criteria:\n\n* 1\\. Women must not be pregnant, breast feeding 2. Chronic oral corticosteroid therapy 3. History of physician-diagnosed nephrolithiasis 4. Chronic diseases（ diabetes，Hypertension，renal insufficiency, severe liver disease） 5.prior surgeries of the paranasal sinuses 6. With an upper respiratory tract infection within 4 weeks of entering the study'}, 'identificationModule': {'nctId': 'NCT02668861', 'briefTitle': 'Effect of Oral Vitamin D3 on Chronic Rhinosinusitis Treatment in Adults With Lower Vitamin D Levels', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Shanxi Medical University'}, 'officialTitle': 'Influence of Oral Vitamin D3 on Wound Healing After Endonasal Endoscopic Sinus Surgery for Chronic Rhinosinusitis With Nasal Polyposis and Lower Vitamin D Levels', 'orgStudyIdInfo': {'id': 'FirstTianjunMU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin D+Budesonide Nasal Spray', 'description': 'Vitamin D 4000IU/day for 8 weeks + Budesonide Nasal Spray 128ug/d for 8 week', 'interventionNames': ['Drug: Vitamin D', 'Drug: Budesonide Nasal Spray']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo+Budesonide Nasal Spray', 'description': 'Placebo for 8 weeks + Budesonide Nasal Spray128ug/d for 8 week', 'interventionNames': ['Drug: Budesonide Nasal Spray', 'Other: placebo']}], 'interventions': [{'name': 'Vitamin D', 'type': 'DRUG', 'description': 'Vitamin D 4000IU/day for 8 weeks', 'armGroupLabels': ['Vitamin D+Budesonide Nasal Spray']}, {'name': 'Budesonide Nasal Spray', 'type': 'DRUG', 'otherNames': ['Rhinocort Aqua'], 'description': 'Budesonide Nasal Spray 128ug/d for 8 week', 'armGroupLabels': ['Vitamin D+Budesonide Nasal Spray', 'placebo+Budesonide Nasal Spray']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'placebo for 8 weeks', 'armGroupLabels': ['placebo+Budesonide Nasal Spray']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taiyuan', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huang F Hui', 'role': 'CONTACT', 'email': '13934518228@163.com', 'phone': '13934518228'}], 'facility': 'The First Hospital of Shanxi Medical University', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}], 'centralContacts': [{'name': 'Jun Tian', 'role': 'CONTACT', 'email': 'zguotian@126.com', 'phone': '13603514451'}, {'name': 'Ying Y Fang', 'role': 'CONTACT', 'email': 'm15703410761@163.com', 'phone': '15703410761'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Shanxi Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jun Tian', 'investigatorAffiliation': 'The First Affiliated Hospital of Shanxi Medical University'}}}}