Vitamin D as adjuvant to subcutaneous specific immunotherapy in patients with allergic
rhinitis Specific allergen immunotherapy is the treatment of choice for patients with
persistent allergic rhinitis. Some strategies to accelerate immunological and clinical
changes to ensure an early response and improve adherence are needed. The administration of
vitamin D along with conventional treatments in allergic patients with asthma or atopic
dermatitis, pathophysiological entities like allergic rhinitis, reduces the severity of
symptoms in less time.
Primary endpoint. To evaluate the efficacy of vitamin D in terms of reducing the time of
therapeutic response to subcutaneous specific allergen immunotherapy.
Compare the time of clinical improvement and adherence to treatment among the group receiving
vitamin D against the group receiving placebo Analyze the relationship between vitamin D
values, total serum IgE, serum eosinophil and nasal cytology in both groups before and after
treatment Assess the safety of vitamin D by serum calcium. TH17 and Treg quantify cells
before and after treatment. MATERIAL AND METHODS This is a interventional, prospective
clinical trial randomized placebo-controlled, double-blind study including paediatric
patients (children 3-12 yr old) with allergic rhinitis, with parallel group: Immunotherapy +
Placebo and Immunotherapy + Vitamin D. Patients prior informed consent include more patients
being female and male of 3 to 12 years old. They will be randomized and in the same
proportion. The sample was calculated using the G Power program to achieve an effect size of
0.65, with alpha = 0.05, statistical power = 80% and 20% losses to mean difference of 2
independent groups, the result was 80 patients, 40 per group. Monitoring will be conducted at
0, 3 and 6 months, assessing clinical and laboratory parameters with the questionnaire RQLQ,
TNSS, CARACT KIDS, ARIA, GINA.
ANALYSIS It will be analyzed in SPSS. The results are expressed by descriptive statistics.
For comparison of means will be used t student. It will be analyzed with ANOVA, variance for
repeated measures in time, general linear model, structural equations, multivariate analysis,
analysis of the main components. P values <0.05 were considered statistically significant.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Hospital General de Mexico
Treatments:
Cholecalciferol Ergocalciferols Vitamin D Vitamins