Vitamin D and Grass Pollen Specific Immunotherapy

Charite University, Berlin, Germany35 enrolled

Overview

Allergen-specific immunotherapy is the only causal therapy of Immunoglobulin E-induced allergies like allergic rhinoconjunctivitis. Despite progress during the last decades it is limited by a long treatment time and high non-responder frequency. Based on experimental and epidemiological evidences we hypothesize that vitamin D can act as an effective immunomodulatory adjuvant to overcome these limitations.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Allergic Rhinoconjunctivitis

Interventions

CholecalciferolDRUG

given orally, once daily, before grass pollen season

middle-chain fatty acids (carrier)OTHER

given orally, once daily, before grass pollen season

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * written informed consent * relative Vitamin D deficiency * clinical relevant grass pollen allergy * positive intradermal test with grass pollen * forced expiratory volume at one second (FEV1) \> 70% Exclusion Criteria: * current specific immunotherapy * instable allergic asthma * pregnancy and lactation * treatment with immunomodulators or immunosuppressive drugs * sarcoidosis, chronic diseases, malignancy

Locations (1)

Charité Universitätsmedizin Berlin, Allergy-Centre-Charité, CCM

Berlin, Germany

Outcomes

Primary Outcomes

wheal diameter in the intradermal test after SIT in the comparison between vitamin D and placebo

Time frame: three years

Data from ClinicalTrials.gov

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