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Evaluation of the effectiveness of adjuvant therapy with Vitamin D3 in children with allergic rhinitis

Protocol summary

Study aim
Evaluation of the Efficacy of Adjunctive Vitamin D3 Therapy in Children with Allergic Rhinitis
Design
A phase 3 randomized controlled trial with parallel groups, single-blind design, conducted on 48 patients. Randomization will be performed using Microsoft Excel.
Settings and conduct
This study is a single-blind randomized clinical trial with primary outcomes of TNSS and RQLQ, including a total of 48 participants under 18 years old with moderate to severe allergic rhinitis, recruited from the allergy clinics of Urmia University of Medical Sciences. Standard therapy, consisting of an oral antihistamine (cetirizine), an oral leukotriene receptor antagonist (montelukast), and a nasal corticosteroid (mometasone), will be administered to both groups. Oral vitamin D3 pearls (1000 IU every other day) will be given exclusively to the intervention group in addition to the standard therapy. Patient information forms will be completed at baseline (week 0) and at 8 weeks, including demographic data (age, sex, weight, height, mode of delivery, type of infant feeding, rural/urban residence), which will be compared after data collection. Since the study is single-blind, participants will not be aware of their assigned intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children with allergic rhinitis. Exclusion criteria: Presence of risk to the participant, non-allergic rhinitis, or lack of consent to participate in the study.
Intervention groups
Oral vitamin D3 pearls (1000 IU every other day)
Main outcome variables
Reduction of symptoms, improvement in sleep quality, improvement in academic performance, relief of fatigue, and alleviation of depressive symptoms.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150426021944N7
Registration date: 2025-10-19, 1404/07/27
Registration timing: prospective

Last update: 2025-10-19, 1404/07/27
Update count: 0
Registration date
2025-10-19, 1404/07/27
Registrant information
Name
Hamidreza Houshmand
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3231 7288
Email address
hamidreza.houshmnd@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-23, 1404/08/01
Expected recruitment end date
2026-03-20, 1404/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of adjuvant therapy with Vitamin D3 in children with allergic rhinitis
Public title
Evaluation of the effectiveness of adjuvant therapy with Vitamin D3 in children with allergic rhinitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children under 18 years with allergic rhinitis Presence of allergic rhinitis symptoms (rhinorrhea, sneezing, nasal congestion, and itching of nose, eyes, throat, and palate) Moderate severity (symptoms ≥4 days per week or ≥4 consecutive weeks) or severe (symptoms with impaired sleep, school, or daily activities) according to ARIA criteria Written informed consent from parents or legal guardians for participation in the study
Exclusion criteria:
Non-allergic rhinitis Anatomical or obstructive nasal disorders (polyp, tumor, bacterial sinusitis, adenoid or tonsillar hypertrophy) Presence of asthma Presence of serious diseases such as kidney disease Use of potent systemic drugs such as oral corticosteroids Use of Vitamin D3 during the past six months Use of medications affecting serum Vitamin D levels (such as antiepileptics, metformin, diuretics, calcium channel blockers, etc) Intolerance to Vitamin D3 pearls Unwillingness to participate in the study or lack of informed consent from parents or legal guardians
Age
To 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
At the beginning, all participants will be evaluated based on their symptoms using the Total Nasal Symptom Score (TNSS), which assesses sneezing, nasal congestion, rhinorrhea, and itching. Participants will then be randomly assigned, using Excel software, into two groups: 24 in the intervention group (standard therapy plus oral Vitamin D3) and 24 in the control group (standard therapy alone), after obtaining written informed consent and the ethics approval code.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, only the participants will be blinded to the type of intervention they receive. Patients will not know whether they are receiving Vitamin D3 in addition to standard therapy or standard therapy alone. The principal investigators and treating physicians will be aware of the intervention due to the nature of the medications. Data collectors and outcome assessors will be blinded to the group assignments in order to minimize bias in the evaluation of outcomes.
Placebo
Not used
Assignment
Parallel
Other design features
Standard therapy, consisting of an oral antihistamine (cetirizine), an oral leukotriene receptor antagonist (montelukast), and a nasal corticosteroid (mometasone), will be administered to both groups. Oral vitamin D3 pearls (1000 IU every other day) will be given exclusively to the intervention group in addition to the standard therapy. Since a prophylactic dose of oral vitamin D3 (1000 IU every other day) is used, no significant increase in blood levels or toxicity is expected.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences, West Azerbaijan
Street address
Vice President of Research and Technology Development, West Azarbaijan University of Medical Sciences and Medical Services, Urmia, Jihad St
City
Urmia
Province
West Azarbaijan
Postal code
5715799313
Approval date
2025-08-27, 1404/06/05
Ethics committee reference number
IR.UMSU.REC.1404.188

Health conditions studied

1

Description of health condition studied
Allergic rhinitis
ICD-10 code
J30
ICD-10 code description
Vasomotor and allergic rhinitis

Primary outcomes

1

Description
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score
Timepoint
Patient information forms will be completed at the baseline visit (week 0) and at 8 weeks, and the collected data will be compared thereafter.
Method of measurement
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)

2

Description
Total Nasal Symptom Score (TNSS)
Timepoint
Patient information forms will be completed at the baseline visit (week 0) and at 8 weeks, and the collected data will be compared thereafter.
Method of measurement
Total Nasal Symptom Score (TNSS) questionnaire

Secondary outcomes

1

Description
Improvement in sleep quality
Timepoint
Patient information forms will be completed at the baseline visit (week 0) and at 8 weeks, and the collected data will be compared thereafter.
Method of measurement
Self-reported

2

Description
Improvement in academic performance
Timepoint
Patient information forms will be completed at the baseline visit (week 0) and at 8 weeks, and the collected data will be compared thereafter.
Method of measurement
Self-reported

3

Description
Relief of fatigue
Timepoint
Patient information forms will be completed at the baseline visit (week 0) and at 8 weeks, and the collected data will be compared thereafter.
Method of measurement
Self-reported

4

Description
Alleviation of depressive symptoms
Timepoint
Patient information forms will be completed at the baseline visit (week 0) and at 8 weeks, and the collected data will be compared thereafter.
Method of measurement
Self-reported

Intervention groups

1

Description
Intervention group: Standard treatment consisted of an oral antihistamine (cetirizine), an oral leukotriene receptor antagonist (montelukast), and a nasal corticosteroid (mometasone) + Recipients of oral vitamin D3 pearls (1000 IU every other day for 8 weeks)
Category
Treatment - Drugs

2

Description
Control group: Standard treatment consisted of an oral antihistamine (cetirizine), an oral leukotriene receptor antagonist (montelukast), and a nasal corticosteroid (mometasone).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Allergi clinic of Urmia university of medical sciences
Full name of responsible person
Hamid reza Hoshmand
Street address
Kasahni Ave. Motahhari Hospital
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 7077
Email
hamidrezahoushmand1347@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Saber Gholizadeh
Street address
Urmia University of Medical Sciences, Orzhans Alley, Resalat St. ,Urmia , Iran
City
urmia
Province
West Azarbaijan
Postal code
5715917611
Phone
+98 44 3223 7082
Fax
+98 44 5453 4654
Email
info@umsu.ac.ir
Web page address
https://en.umsu.ac.ir/Vice-Chancellor-for-Research
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
ِِDr. Hamid Reza Houshmand
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Kashani street
City
Orumia
Province
West Azarbaijan
Postal code
57159-74677
Phone
0098 44 3334592
Email
hamidreza.houshmand@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
ِِDr. Hamid Reza Houshmand
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Kashani street
City
Orumia
Province
West Azarbaijan
Postal code
57159-74677
Phone
0098 44 3334592
Email
hamidreza.houshmand@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
ِِDr. Hamid Reza Houshmand
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Kashani street
City
Orumia
Province
West Azarbaijan
Postal code
57159-74677
Phone
0098 44 3334592
Email
hamidreza.houshmand@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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