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Evaluation of the effect of vitamin D on recurrence of chronic rhinosinusitis associated with nasal polyposis after functional endoscopic sinus surgery (Triple blind, Placebo-controlled randomized clinical trial)

Protocol summary

Study aim
Determining the effect of vitamin D on recurrence of chronic nasal sinusitis with polyposis
Design
triple blind, Placebo-controlled randomized clinical trial with control group, phase 3 on 100 patients.
Settings and conduct
The statistical population includes patients referred to Amiralam Hospital with chronic nasal sinusitis with polyposis, which are randomly divided into placebo and intervention groups. The intervention group is treated with vitamin D3 for 6 months. The control group is given a placebo. The study is triple blind and the participants, the surgeon and the statistician who performs the study analysis, are kept blind to being assigned to the study groups.
Participants/Inclusion and exclusion criteria
The statistical population includes patients referred to Amir Alam's Hospital with chronic nasal sinusitis with polyposis in the age range of 18 to 65 years. Exclusion criteria in the study include: dissatisfaction, Getting Covid-19 and taking vitamin D followed during the study, acute complications of chronic sinusitis, Immunosuppressive drug use, Contraceptive drug use (OCP), Anti TB drug use, Patients with active infection, Recent hypercalcemia or history of hypercalcemia, Anticonvulsant drug, Kidney stone, Recent tanning history, Pregnancy, Breastfeeding, history of malabsorption, vitamin D levels above 80, continuous intake of vitamin D3 supplementation of more than 400 units per day, acute exacerbation of acute bacterial sinusitis.
Intervention groups
Both control and intervention groups will be divided into three subgroups. The intervention group is then treated with vitamin D3 for 6 months. The control group is given a placebo.
Main outcome variables
The effect of vitamin D on endoscopic score of patients with nasal polyposis based on Lund Kennedy score and SNOT 22, CT scan and endoscopy results

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211026052878N1
Registration date: 2021-12-18, 1400/09/27
Registration timing: registered_while_recruiting

Last update: 2021-12-18, 1400/09/27
Update count: 0
Registration date
2021-12-18, 1400/09/27
Registrant information
Name
Shirin Irani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6670 3037
Email address
sh_irani@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-11, 1400/09/20
Expected recruitment end date
2022-12-11, 1401/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of vitamin D on recurrence of chronic rhinosinusitis associated with nasal polyposis after functional endoscopic sinus surgery (Triple blind, Placebo-controlled randomized clinical trial)
Public title
The effect of vitamin D on recurrence of chronic rhinosinusitis associated with nasal polyposis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients referred to Amiralam Hospital with chronic nasal sinusitis with polyposis
Exclusion criteria:
Dissatisfaction Getting Covid 19 and getting vitamin D followed while studying Patients with acute complications of chronic sinusitis Taking immunosuppressive drugs Contraceptive drug use (OCP) Taking Anti TB drugs Patients with active infection Recent hypercalcemia or history of hypercalcemia Get anticonvulsant medicine Nephrolithiasis Recent tanning history Pregnancy Breastfeeding History of malabsorption Vitamin D levels above 80 Continuous vitamin D3 supplementation over 400 units per day Acute exacerbation of acute bacterial sinusitis
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked Randomization is used. Four blocks of defined intervention (A) and control (B) groups (AABB, ABAB, ABBA, BBAA, BABA, BAAB) and written on cards 1-6, the cards are placed in the envelope. The cards are then randomly selected and a random string is made from the selected card sequence. Patients in the intervention and control groups are included in the study based on this sequence.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants, the surgeon, the statistician who analyzes the study are kept blind to their assignment to study groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee Tehran of University of Medical Sciences
Street address
Keshavarz Blvd., Ghods St., Vice Chancellor for Research and Technology, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2021-10-17, 1400/07/25
Ethics committee reference number
IR.TUMS.AMIRALAM.REC.1400.034

Health conditions studied

1

Description of health condition studied
Chronic rhinosinusitis with nasal polyposis
ICD-10 code
J32.9
ICD-10 code description
Chronic sinusitis, unspecified

Primary outcomes

1

Description
Patient score in SNOT-22 questionnaire
Timepoint
One month, three months and six months after surgery
Method of measurement
The Sino-Nasal Outcome Test (SNOT-22)

2

Description
Patient score in Lund-Mackay score of CT scan
Timepoint
One month, three months and six months after surgery
Method of measurement
Lund-Mackay score of CT scan

3

Description
Patient score in Lund-Kennedy score
Timepoint
One month, three months and six months after surgery
Method of measurement
Lund-Kennedy score

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients with chronic rhinosinusitis associated with polyposis treated with vitamin D. Both control and intervention groups will be divided into three subgroups. The first subgroup has a vitamin D level below 20 ng / ml (deficient), the second subgroup has a vitamin D level of 20-29 ng / ml (Insufficient), the third subgroup has a vitamin D level greater than 30 ng / ml (Sufficient).The first subgroup receives 50,000 units of vitamin D eight weeks weekly and then monthly. The second subgroup receives 50,000 units of vitamin D eight weeks weekly and then monthly. The third subgroup receives 50,000 units of vitamin D per month.
Category
Treatment - Drugs

2

Description
Control group: Patients with chronic rhinosinusitis associated with polyposis treated with placebo in a similar way.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
ENT Clinic of Amir Alam Hospital
Full name of responsible person
Leyla Noury
Street address
Enghelab St., North Saadi, ENT Clinic of Amir Alam Hospital
City
Tehran
Province
Tehran
Postal code
141765371
Phone
+98 21 6670 6106
Email
leyla.noury@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Keshavarz Boulevard, Qods Street
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8898 7381
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Leyla Noury
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
North Saadi Street, the new building of Amir Alam Hospital
City
Tehran
Province
Tehran
Postal code
1145755811
Phone
+98 21 6670 6106
Email
leyla.noury@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Leyla Noury
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
North Saadi Street, the new building of Amir Alam Hospital
City
Tehran
Province
Tehran
Postal code
1145755811
Phone
+98 21 6670 6106
Email
leyla.noury@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Leyla Noury
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
North Saadi Street, the new building of Amir Alam Hospital
City
Tehran
Province
Tehran
Postal code
1145755811
Phone
+98 21 6670 6106
Email
leyla.noury@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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