NCT04529668

Brief Summary

Aim of the work

  1. 1.To determine if chronic rhinosinusitis with nasal polyps' (CRSwNP) populations are vitamin D deficient.
  2. 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2015

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2020

Completed
Last Updated

August 31, 2020

Status Verified

August 1, 2020

Enrollment Period

5 years

First QC Date

August 25, 2020

Last Update Submit

August 27, 2020

Conditions

Vitamin D Deficiency, Nasal Polyposis

Keywords

VITAMIN D DEFICIENCY, CHRONIC RHINOSINUSITIS WITH NASAL POLYPOSIS

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

group I

EXPERIMENTAL

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

Drug: 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

Drug: usual therapy for nasal polyposis

Interventions

vitamin D supplementationDRUG

vitamin D supplementation

group I
usual therapy for nasal polyposisDRUG

steroids ( systemic and local )

group II

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients (18-60) years of age with clinical diagnosis of chronic rhinosinusitis with nasal Polyposis (CRSwNP) at Otorhinolaryngology outpatient clinic, Ain Shams University hospital.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shams Univesrity

Cairo, Egypt

RECRUITING

Related Publications (1)

  • 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.

    PMID: 22469599RESULT

MeSH Terms

Conditions

Vitamin D DeficiencyNasal Polyps

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Fatma S Ebeid, MD

CONTACT

+20109556 9596dr.fatma_ebeid@yahoo.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
all will be masked
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

August 25, 2020

First Posted

August 27, 2020

Study Start

October 1, 2015

Primary Completion

October 1, 2020

Study Completion

October 20, 2020

Last Updated

August 31, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)