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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20150426021944N7
Enrollment
48
Registered
2025-10-19
Start date
2025-10-23
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic rhinitis. Vasomotor and allergic rhinitis

Interventions

Intervention 1: Intervention group: Standard treatment consisted of an oral antihistamine (cetirizine), an oral leukotriene receptor antagonist (montelukast), and a nasal corticosteroid (mometasone) +

Sponsors

Oroumia University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public Contact??Dr. Hamid Reza Houshmand

Oroumia University of Medical Sciences

hamidreza.houshmand@gmail.com0098 44 3334592

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026