Study objective: finding a better and more cost-effective way to treat chronic rhinosinusitis with and without polyposis. Study design: randomized, double-blind, placebo-controlled, single centre.
Inclusion criteria: all patients older than 18 years with the diagnostic criteria for chronic rhinosinusitis with polyposis based on the EPOS 2012 criteria. Exclusion criteria: smoking; sensitivity to vitamin D3; pregnancy; use of systemic steroids in last month; immunosuppressive drugs; history of any endocrine disease; malignancy; acute rhinosinisitis during study; surgery for rhinosinusitis; complication of rhinosinusitis; calcification of soft tissue and hypercalcemia.
The patients divided to 2 groups by block randomization. Intervention group will receive fluticasone nasal spray (2 puffs in each nasal cavity, once a day) and calcitriol spray (2 puffs in each nasal cavity equivalent to 2,000 units of vitamin D or 50 micrograms of calcitriol, once a day) for one month, and the control group will receive fluticasone nasal spray and placebo in the same dose. VAS and SNOT-22, and endoscopic exam questionnaire will be completed before and after intervention (at the first and third month).
Sample size:60. Blinding: fluticasone and placebo spray will be prepared in similar bottles and coded by pharmacist and will be delivered to the researcher; so neither researcher nor the patients will find out about the contents of the bottles.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201705173186N11
Registration date:2017-10-20, 1396/07/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-20, 1396/07/28
Registrant information
Name
Farnaz Hashemian
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3827 9001
Email address
hashemian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan university of medical scinnce
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of topical calcitriol on Chronic Rhinosinusitis with and without polyps
Public title
Assessment of the effect of topical calcitriol on Chronic Rhinosinusitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all patients older than 18 years with the diagnostic criteria for chronic rhinosinusitis with polyposis based on the EPOS 2012 criteria. Exclusion criteria: smoking; sensitivity to vitamin D3; pregnancy; use of systemic steroids in last month; immunosuppressive drugs; history of any endocrine disease, malignancy, acute rhinosinisitis during study, surgery for rhinosinusitis, complication of rhinosinusitis, calcification of soft tissue and hypercalcemia.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan university of medical sciences
Street address
Shahid Fahmideh Ave., Hamadan
City
Hamadan
Postal code
65178
Approval date
2017-04-08, 1396/01/19
Ethics committee reference number
IR.UMSHA.REC.1396.9
Health conditions studied
1
Description of health condition studied
chronic rhinosinusitis with and without polyps
ICD-10 code
J32
ICD-10 code description
chronic sinusitis
Primary outcomes
1
Description
chronic rhinosinusitis
Timepoint
Before intervention and 1and 3 months after intervention
Method of measurement
VAS, SNOT22 and Lund Kennedy scoring
Secondary outcomes
1
Description
drug adverse effect such as nasal irritation
Timepoint
during study period
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: nasal spray fluticasone once a day, 2 puff in each nasal cavity with calcitriol spray once a day (equivalent 2000 unit vitamin D or 50 micro gram calcitriol) for one month
Category
Treatment - Drugs
2
Description
control group: nasal spray fluicasone and placebo
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
hamadan besat hospital, ENT clinic
Full name of responsible person
Dr.farnaz hashemian
Street address
ENT clinic, Besat Hospital, shahid Motahari Blvd., Hamadan, Iran
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Hamadan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Shahid Fahmideh Ave., Hamadan University of Medical Sciences
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Farnaz Hashemian
Position
Associate professor
Other areas of specialty/work
Street address
Besat hospital, Shahid Motahari Blvd., Hamadan
City
Hamadan
Postal code
Phone
+98 81 3264 0047
Fax
Email
hashemian@umsha.ac.ir- farnazhashemian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Farnaz Hashemian
Position
Associate professor
Other areas of specialty/work
Street address
Besat hospital, shahid Motahari Blvd, Hamadan
City
Hamadan
Postal code
Phone
+98 81 3264 0047
Fax
Email
Hashemian@umsha.ac.ir;farnazhashemian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Farnaz Hashemian
Position
Associate professor
Other areas of specialty/work
Street address
Besat hospital, Shahid Motahari Blvd, Hamadan
City
Hamadan
Postal code
Phone
+98 81 3264 0047
Fax
Email
Hashemian@umsha.ac.ir;farnazhashemian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)