D2.151 - Study design for A multicenter, open label, randomized Study to inveStigate the effIcacy of Subcutaneous immunoTherapy combined with vitamin D3 in children and adolescent patients with allergic rhinitis (ASSIST study)

The global incidence of allergic rhinitis (AR) is escalating, particularly in children. Allergen immunotherapy (AIT) has been established as the only etiological treatment for AR. Studies demonstrated that vitamin D3 deficiency is associated with an increased risk of allergic diseases. Additionally, small-scale studies indicated that vitamin D3 supplementation may enhance the efficacy of AIT in patients with allergic conditions. Thus, this large-scale multicenter study aims to assess the efficacy and safety of SCIT combined vitamin D3 supplementation in Chinese children with AR.

The ASSIST study is a multicentric, randomized, open-label clinical trial involving 19 centers across China. A total of 255 children and adolescents (aged 5 to 18 years) diagnosed with moderate to severe HDM-induced AR and having a serum 25(OH)D level ranging from 50 to 250 nmol/L will be recruited. All participants will be randomized into three groups: SCIT combined with vitamin D3 supplementation for 3 months, SCIT combined with vitamin D3 supplementation for 6 months and SCIT alone. Effectiveness will be evaluated using VAS and the Combined Symptom and Medication Score (CSMS). Additionally, levels of 25(OH)D, total IgE, sIgE, and eosinophils will be tested. Adverse reactions will be collected to assess safety.

It is hypothesized that the combination of SCIT and vitamin D3 supplementation will lead to a significant improvement in VAS and CSMS scores as compared to SCIT alone.

The combination of SCIT with vitamin D3 may be more efficacious in alleviating the symptoms of rhinitis patients. Vitamin D3 supplementation could potentially be a convenient and economical way to further improve the efficacy of SCIT, thus augmenting the clinical advantages for children and adolescent patients.