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Allergic Rhinitis, Immunotherapy and Vitamin d

NCT02738619 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-04-14

No results posted yet for this study

Summary

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.

Conditions

  • Allergy

Interventions

DRUG

Vitamin D3

1600 UI

DRUG

placebo

placebo

Sponsors & Collaborators

  • Hospital General de Mexico

    lead OTHER_GOV

Principal Investigators

  • joselin hernandez, dr · Hospital General de Mexico

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Mexico

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02738619 on ClinicalTrials.gov