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IRCT20150426021944N7 IRCT 2025-10-19 Oroumia University of Medical Sciences Evaluation of the effectiveness of adjuvant therapy with Vitamin D3 in children with allergic rhinitis Evaluation of the effectiveness of adjuvant therapy with Vitamin D3 in children with allergic rhinitis 2025-10-23 anticipated 48 Complete https://irct.ir/trial/86494 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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, 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 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. 3 Allergic rhinitis. Intervention 1: 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). Intervention 2: Control group: Standard treatment consisted of an oral antihistamine (cetirizine), an oral leukotriene receptor antagonist (montelukast), and a nasal corticosteroid (mometasone). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The publication schedule has not been determined yet.
public ِِDr. Hamid Reza Houshmand
Kashani street
Orumia Iran (Islamic Republic of) 57159-74677 0098 44 3334592 hamidreza.houshmand@gmail.com Oroumia University of Medical Sciences scientific ِِDr. Hamid Reza Houshmand
Kashani street
Orumia Iran (Islamic Republic of) 57159-74677 0098 44 3334592 hamidreza.houshmand@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) 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 no limit 18 years Both 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 J30 Vasomotor and allergic rhinitis Treatment - Drugs Treatment - Drugs 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) Control group: Standard treatment consisted of an oral antihistamine (cetirizine), an oral leukotriene receptor antagonist (montelukast), and a nasal corticosteroid (mometasone). 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). 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. 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. 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. 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. 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. Oroumia University of Medical Sciences Approved 2025-08-27 Ethics Committee of Urmia University of Medical Sciences, West Azerbaijan Vice President of Research and Technology Development, West Azarbaijan University of Medical Sciences and Medical Services, Urmia, Jihad St Urmia West Azarbaijan Iran (Islamic Republic of)