Effect of Vitamin d Deficiency in Chronic Rhinosinusitis With Nasal Polyposis

Ain Shams University

Status and phase: Unknown; Phase 1

Conditions: Vitamin D Deficiency, Nasal Polyposis

Treatments: Drug: usual therapy for nasal polyposis; Drug: vitamin D supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT04529668

FMASUMD241/2015

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

group I

Experimental group

Description:

twenty-five patients with the clinical diagnosis of chronic rhinosinusitis with nasal Polyposis will receive vitamin D supplementation

Treatment:

Drug: vitamin D supplementation

group II

Active Comparator group

Description:

twenty-five patients with the clinical diagnosis of chronic rhinosinusitis with nasal Polyposis will NOT receive vitamin D supplementation

Treatment:

Drug: usual therapy for nasal polyposis