Allergic Rhinoconjunctivitis
Conditions
Keywords
Vitamin D, SIT, Grass pollen, allergic rhinoconjunctivitis
Brief summary
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.
Interventions
DRUGCholecalciferol
given orally, once daily, before grass pollen season
OTHERmiddle-chain fatty acids (carrier)
given orally, once daily, before grass pollen season
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| wheal diameter in the intradermal test after SIT in the comparison between vitamin D and placebo | three years |
Countries
Germany
Outcome results
None listed