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Aim of the work
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:
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:
Examination:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group I | Experimental | twenty-five patients with the clinical diagnosis of chronic rhinosinusitis with nasal Polyposis will receive vitamin D supplementation |
|
| group II | Active Comparator | twenty-five patients with the clinical diagnosis of chronic rhinosinusitis with nasal Polyposis will NOT receive vitamin D supplementation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamin D supplementation | Drug | vitamin D supplementation |
| |
| usual therapy for nasal polyposis |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 weeks |
| 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 | 6 weeks |
| histopathology | immunohistochemitsry for fibroblast growth factor | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
• Pregnant and lactating females.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fatma S Ebeid, MD | Contact | +20109556 9596 | dr.fatma_ebeid@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain shams Univesrity | Recruiting | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22469599 | Result | 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. |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| D009298 | Nasal Polyps |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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all will be masked
| Drug |
steroids ( systemic and local ) |
|
| D009750 |
| Nutritional and Metabolic Diseases |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |