Comparing the effects of zinc supplementation on reducing polyp recurrence in patients with chronic rhinosinusitis and inflammatory and allergic nasal polyps referred to Taleghani Hospital
Comparing the effects of zinc supplementation on reducing polyp recurrence in patients with chronic rhinosinusitis and inflammatory and allergic nasal polyps referred to Taleghani Hospital
Design
This study is a phase 1-2, randomized, single-blind, placebo-controlled, parallel-group clinical trial involving 40 patients. Participants will be randomly allocated in a 1:1 ratio to either the intervention group or the placebo group using a block randomization technique.
Settings and conduct
This randomized, placebo-controlled trial will enroll patients with chronic rhinosinusitis and allergic/inflammatory nasal polyps from Taleghani Hospital. Participants will be randomly assigned to either the treatment or placebo group, with strict blinding maintained to prevent bias in outcome assessment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: no underlying systemic conditions. Additionally, must not have taken zinc supplements within the past 3 months. Exclusion criteria: lost to follow-up after surgery, if histopathological examination revealed any diagnosis other than sinonasal polyposis, or if they failed to adhere to the prescribed postoperative medication regimen.
Intervention groups
Postoperatively, patients in the first group will receive a 1-month course of oral prednisolone at a dose of 0.5 mg/kg of body weight. This will be followed by a 3-month regimen consisting of: 20 mL normal saline nasal irrigation in both nostrils four times daily, topical steroid administration every 12 hours, and one daily 220 mg zinc sulfate capsule (equivalent to 55 mg of elemental zinc) (Alhavipharma company). The second group of patients (control group) will receive the same treatment regimen without zinc sulfate supplementation. Instead of zinc, they will be given a placebo.
Main outcome variables
Polyp recurrence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190122042460N1
Registration date:2025-05-18, 1404/02/28
Registration timing:prospective
Last update:2025-05-18, 1404/02/28
Update count:0
Registration date
2025-05-18, 1404/02/28
Registrant information
Name
Matin Ghazizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2303 1317
Email address
matinghazizadeh@sbmu.ac.ir
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2025-05-31, 1404/03/10
Expected recruitment end date
2025-12-01, 1404/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of zinc supplementation on reducing polyp recurrence in patients with chronic rhinosinusitis and inflammatory and allergic nasal polyps referred to Taleghani Hospital
Public title
The effects of zinc supplementation on reducing polyp recurrence in patients with chronic rhinosinusitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Without underlying diseases including cystic fibrosis, Kartagener syndrome, Wegener's vasculitis, vasculitides, sarcoidosis, and rheumatologic diseases.
They should not have taken zinc as a dietary supplement in the past 3 months.
The patients included in the study must not have received systemic corticosteroid therapy or undergone previous sinus surgery.
Exclusion criteria:
No postoperative follow-up.
Any histopathological diagnosis other than sinonasal polyposis (SNP), such as malignancies.
No postoperative medication use.
Age
From 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with neutrophilic and eosinophilic polypoid rhinosinusitis will be equally randomized into intervention and placebo groups in a 1:1 ratio using block randomization technique.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the patients are all unaware of the type of intervention being administered to the patients.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine - Shahid Beheshti University of Medical Sciences
Street address
Arabi St, Yaman Ave, Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1985717413
Approval date
2025-04-29, 1404/02/09
Ethics committee reference number
IR.SBMU.MSP.REC.1404.028
Health conditions studied
1
Description of health condition studied
Polyp
ICD-10 code
J33
ICD-10 code description
Nasal polyp
Primary outcomes
1
Description
Polyp recurrence
Timepoint
Before the intervention, and at 1, 3, and 6 months after the intervention
Method of measurement
Clinical examination and Sino-nasal Outcome Test (SNOT-22) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Postoperatively, patients in the first group will receive a 1-month course of oral prednisolone at a dose of 0.5 mg/kg of body weight. This will be followed by a 3-month regimen consisting of: 20 mL normal saline nasal irrigation in both nostrils four times daily, topical steroid administration every 12 hours, and one daily 220 mg zinc sulfate capsule (equivalent to 55 mg of elemental zinc) (Alhavipharma company).
Category
Treatment - Drugs
2
Description
Control group: The second group of patients (control group) will receive the same treatment regimen without zinc sulfate supplementation. Instead of zinc, they will be given a placebo.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Taleghani Educational Hospital
Full name of responsible person
Matin Ghazizadeh
Street address
Arabi St, Yaman Ave, Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2303 1122
Email
info@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Arabi St, Yaman Ave, Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2303 1317
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?