Effect of Vitamin d Deficiency in Chronic Rhinosinusitis With Nasal Polyposis
Primary Purpose
Vitamin D Deficiency, Nasal Polyposis
Status
Unknown status
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
vitamin D supplementation
usual therapy for nasal polyposis
Sponsored by
About this trial
This is an interventional treatment trial for Vitamin D Deficiency, Nasal Polyposis focused on measuring VITAMIN D DEFICIENCY, CHRONIC RHINOSINUSITIS WITH NASAL POLYPOSIS
Eligibility Criteria
Inclusion Criteria:
- Patients (18-60) years of age with clinical diagnosis of chronic rhinosinusitis with nasal Polyposis (CRSwNP) at Otorhinolaryngology outpatient clinic, Ain Shams University hospital.
Exclusion Criteria:
• Pregnant and lactating females.
- Patients taking multivitamins containing vitamin D for at least six months.
- Immune deficiency or suppression.
- Ciliary motility disorders.
- Wegner's granulomatosis and other granulomatous diseases.
- Sino-nasal malignancy.
Sites / Locations
- Ain shams UnivesrityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
group I
group II
Arm Description
twenty-five patients with the clinical diagnosis of chronic rhinosinusitis with nasal Polyposis will receive vitamin D supplementation
twenty-five patients with the clinical diagnosis of chronic rhinosinusitis with nasal Polyposis will NOT receive vitamin D supplementation
Outcomes
Primary Outcome Measures
patient complaint
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
examintaion
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
histopathology
immunohistochemitsry for fibroblast growth factor
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04529668
Brief Title
Effect of Vitamin d Deficiency in Chronic Rhinosinusitis With Nasal Polyposis
Official Title
Effect of Vitamin d Deficiency in Chronic Rhinosinusitis With Nasal Polyposis: Clinical, Laboratory & Immunohistochemical Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2015 (Actual)
Primary Completion Date
October 1, 2020 (Anticipated)
Study Completion Date
October 20, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Aim of the work
To determine if chronic rhinosinusitis with nasal polyps' (CRSwNP) populations are vitamin D deficient.
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
Detailed Description
Patients & methods
Study groups:
Fifty 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.
Inclusion criteria:
Patients (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.
Both groups (I & II) will be subjected to venous blood sampling and 25(OH) vitamin D level measurement & will be subjected to:
Careful history taking.
Complete ENT examination and endoscopic evaluation of the nose.
CT scan paranasal sinuses coronal and axial view to evaluate the affected sinuses.
Vitamin D3 serum level (before Vitamin D3 supplementation).
Biopsy from nasal polyps & immunohistochemical assessment (before Vitamin D3 supplementation).
Vitamin D3 supplementation 50000 IU/weekly for 6 weeks.
Vitamin D3 serum level (after Vitamin D3 supplementation).
Biopsy from nasal polyps & immunohistochemical assessment (after Vitamin D3 supplementation).
Exclusion criteria:
Pregnant and lactating females.
Patients taking multivitamins containing vitamin D for at least six months.
Immune deficiency or suppression.
Ciliary motility disorders.
Wegner's granulomatosis and other granulomatous diseases.
Sino-nasal malignancy.
History:
Personal history: name, age, sex, occupation and environment (smoking, exposure to irritants).
Complaint and history of present illness: analysis of the patient's chief complaints with special emphasis on CRS symptoms.
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.
Family history: History of allergy, asthma, polyposis, migraine, genetic diseases, etc….
Examination:
General examination: it will be done for all patients as a routine.
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.
Endoscopic examination: Diagnostic nasal endoscopy will be done for all patients.
Investigations:
A- CT scans will be done (in coronal, axial planes) for all patients with chronic rhinosinusitis with nasal Polyposis (CRSwNP).
B- 25-OH Vitamin D serum level: (before & after vitamin D supplementation)
Biopsy from nasal polyps :
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.
Vitamin D3 supplementation:
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.
Biopsy from nasal polyps :
Tissue 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, Nasal Polyposis
Keywords
VITAMIN D DEFICIENCY, CHRONIC RHINOSINUSITIS WITH NASAL POLYPOSIS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
all will be masked
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group I
Arm Type
Experimental
Arm Description
twenty-five patients with the clinical diagnosis of chronic rhinosinusitis with nasal Polyposis will receive vitamin D supplementation
Arm Title
group II
Arm Type
Active Comparator
Arm Description
twenty-five patients with the clinical diagnosis of chronic rhinosinusitis with nasal Polyposis will NOT receive vitamin D supplementation
Intervention Type
Drug
Intervention Name(s)
vitamin D supplementation
Intervention Description
vitamin D supplementation
Intervention Type
Drug
Intervention Name(s)
usual therapy for nasal polyposis
Intervention Description
steroids ( systemic and local )
Primary Outcome Measure Information:
Title
patient complaint
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
Time Frame
6 weeks
Title
examintaion
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
Time Frame
6 weeks
Title
histopathology
Description
immunohistochemitsry for fibroblast growth factor
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients (18-60) years of age with clinical diagnosis of chronic rhinosinusitis with nasal Polyposis (CRSwNP) at Otorhinolaryngology outpatient clinic, Ain Shams University hospital.
Exclusion Criteria:
• Pregnant and lactating females.
Patients taking multivitamins containing vitamin D for at least six months.
Immune deficiency or suppression.
Ciliary motility disorders.
Wegner's granulomatosis and other granulomatous diseases.
Sino-nasal malignancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fatma S Ebeid, MD
Phone
+20109556 9596
Email
dr.fatma_ebeid@yahoo.com
Facility Information:
Facility Name
Ain shams Univesrity
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatma S Ebeid, MD
Phone
+20109556 9596
Email
dr.fatma_ebeid@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22469599
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.
Results Reference
result
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Effect of Vitamin d Deficiency in Chronic Rhinosinusitis With Nasal Polyposis
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