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

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

Study Overview

• Status: Unknown
• Conditions: Vitamin D Deficiency, Nasal Polyposis
• Intervention / Treatment: Drug: vitamin D supplementation; Drug: usual therapy for nasal polyposis

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Ain shams Univesrity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group I; twenty-five patients with the clinical diagnosis of chronic rhinosinusitis with nasal Polyposis will receive vitamin D supplementation	Drug: vitamin D supplementation; vitamin D supplementation
Active Comparator: group II; twenty-five patients with the clinical diagnosis of chronic rhinosinusitis with nasal Polyposis will NOT receive vitamin D supplementation	Drug: usual therapy for nasal polyposis; steroids ( systemic and local )

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Ain Shams University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): October 20, 2020

Study Registration Dates

• First Submitted: August 25, 2020
• First Submitted That Met QC Criteria: August 25, 2020
• First Posted (Actual): August 27, 2020

Study Record Updates

• Last Update Posted (Actual): August 31, 2020
• Last Update Submitted That Met QC Criteria: August 27, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: VITAMIN D DEFICIENCY, CHRONIC RHINOSINUSITIS WITH NASAL POLYPOSIS
• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Nutrition Disorders; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Rectal Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nose Diseases; Polyps; Nasopharyngeal Neoplasms; Colorectal Neoplasms; Vitamin D Deficiency; Nasal Polyps; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: FMASUMD241/2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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