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Effect of Vitamin d Deficiency in Chronic Rhinosinusitis With Nasal Polyposis

Effect of Vitamin d Deficiency in Chronic Rhinosinusitis With Nasal Polyposis: Clinical, Laboratory & Immunohistochemical Study

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04529668
Enrollment
50
Registered
2020-08-27
Start date
2015-10-01
Completion date
2020-10-20
Last updated
2020-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D Deficiency, Nasal Polyposis

Keywords

VITAMIN D DEFICIENCY, CHRONIC RHINOSINUSITIS WITH NASAL POLYPOSIS

Brief summary

Aim of the work 1. To determine if chronic rhinosinusitis with nasal polyps' (CRSwNP) populations are vitamin D deficient. 2. 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: 1. Careful history taking. 2. Complete ENT examination and endoscopic evaluation of the nose. 3. CT scan paranasal sinuses coronal and axial view to evaluate the affected sinuses. 4. Vitamin D3 serum level (before Vitamin D3 supplementation). 5. Biopsy from nasal polyps & immunohistochemical assessment (before Vitamin D3 supplementation). 6. Vitamin D3 supplementation 50000 IU/weekly for 6 weeks. 7. Vitamin D3 serum level (after Vitamin D3 supplementation). 8. 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. 1. History: 1. Personal history: name, age, sex, occupation and environment (smoking, exposure to irritants). 2. Complaint and history of present illness: analysis of the patient's chief complaints with special emphasis on CRS symptoms. 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. 4. Family history: History of allergy, asthma, polyposis, migraine, genetic diseases, etc…. 2. Examination: 1. General examination: it will be done for all patients as a routine. 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. 3. Endoscopic examination: Diagnostic nasal endoscopy will be done for all patients. 3. 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) 4. 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. 5. 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. 6. 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.

Interventions

DRUGvitamin D supplementation

vitamin D supplementation

DRUGusual therapy for nasal polyposis

steroids ( systemic and local )

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

all will be masked

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
patient complaint6 weeksby 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
examintaion6 weeksLund & Kennedy endoscopic appearance score, examination will be done before and after vitamin D supplementation , with 0 means absent finding and 2 means worst finding
histopathology6 weeksimmunohistochemitsry for fibroblast growth factor

Countries

Egypt

Contacts

Primary ContactFatma S Ebeid, MD
dr.fatma_ebeid@yahoo.com+20109556 9596

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026