Allergic Rhinitis, Immunotherapy and Vitamin d

NCT02738619 | Unknown Phase 2 DMC

• 1 other identifier: DI/15/309/04/042
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

allergic rhinitis; immunotherapy; vitamin D

Outcome Measures

Primary Outcomes (2)

• Rhino-conjunctivitis Questionnaire (symptom severity)

  Rhino-conjunctivitis Questionnaire (symptom severity) \[ Time Frame: Baseline \] \[ Designated as safety issue: No \] 10cm visual analogue scale used in a 28-item questionnaire to evaluate their symptoms severity.

  Time Frame: Baseline

• Rhino-conjunctivitis Questionnaire (symptom severity)

  Rhino-conjunctivitis Questionnaire (symptom severity) \[ Time Frame: 3 months after intervention \] \[ Designated as safety issue: No \] 10cm visual analogue scale used in a 28-item questionnaire to evaluate their symptoms severity.

  Time Frame: 3 months after intervention

Study Arms (2)

vitamin d3

ACTIVE COMPARATOR

1600 UI

Drug: Vitamin D3

placebo

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

Vitamin D3 DRUG

1600 UI

Also known as: vitamin d

vitamin d3

placebo DRUG

placebo

placebo

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients female and male of 5-13 years diagnosed with persistent allergic rhinitis according to ARIA guide
• To sign the consent and legal representatives informed consent and patient.
• Being sensitized to a aeroallergen and are candidates for specific immunotherapy.
• Let them bring serum levels of 25 (OH) D less than 30 ng / ml
• are in Stage 1 or 2 Tanner.
• BMI within the normal range (between 5 and 85 percentiles)

You may not qualify if:

• primary and / or secondary immunodeficiencies
• Chronic nasal polyposis
• Adenoiditis and / or tonsillitis candidates for surgical resolution
• have taken vitamin D in the last 6 months.
• have used specific allergen immunotherapy in the last 5 years.

Sponsors & Collaborators

• Hospital General de Mexico: lead

Study Sites (1)

Juan Carlos Fernandez de Cordova Aguirre

Mexico City, Mexico City, 14080, Mexico

RECRUITING

MeSH Terms

Conditions

Hypersensitivity; Rhinitis, Allergic

Interventions

Cholecalciferol; Vitamin D

Condition Hierarchy (Ancestors)

Immune System Diseases; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids

Study Officials

• joselin hernandez, dr

  Hospital General de Mexico

  STUDY DIRECTOR

Central Study Contacts

juan c fernandez de cordova, md

CONTACT

5551043578; drjuanfdcordova@gmail.com

guillermo velazquez, md

CONTACT

5551043578; gvelazquezsamano@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr

Study Record Dates

• First Submitted: April 6, 2016
• First Posted: April 14, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 14, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share

Locations

ME (1)