Trial intelligence / Profile preview

Vitamin D as Adjuvant to Immunotherapy in Allergic Rhinitis

NCT02738619Phase 3

Key facts

Status: Unknown
Start: Mar 2016
Primary completion: Dec 2016
Countries: 1
Sponsor: Hospital General de México "Dr. Eduardo Liceaga"
Modality: Orthosteric Ligands, Metabolically Activated Prodrugs

Drugs: vitamin d
Conditions: allergic rhinitis (AR)

Overview

Phase 3, randomised, double-blind trial in allergic rhinitis (AR) comparing Immunotherapy + Vitamin D with Immunotherapy + Placebo (2 arms). Primary endpoints: Rhino-conjunctivitis Quality of Life Questionnaire at 3 months and Time to therapeutic response at 6 months. Status: unknown.

Design

2 arms

Study design: RandomizedDouble-blind

Immunotherapy + Vitamin D
Subcutaneous Specific Immunotherapy + Vitamin D3 (1600 IU)
Immunotherapy + Placebo
Subcutaneous Specific Immunotherapy + Placebo

Who it enrols

Children aged 5-13 with persistent allergic rhinitis sensitized to an aeroallergen, with Vitamin D deficiency (<30 ng/ml), Tanner stage 1 or 2, and normal BMI.

Endpoints

Primary

Rhino-conjunctivitis Quality of Life Questionnaire3 months
Time to therapeutic response6 months

Secondary

Adherence to treatment6 months
Total Serum IgE6 months
Serum Eosinophil Count6 months
Nasal Cytology6 months
Serum Calcium6 months
Regulatory T Cells (Treg)6 months
T Helper 17 Cells (TH17)6 months

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