Vitamin D and Grass Pollen Specific Immunotherapy
Phase 2
Completed
- Conditions
- Allergic Rhinoconjunctivitis
- Interventions
- Other: middle-chain fatty acids (carrier)
- Registration Number
- NCT01466465
- Lead Sponsor
- Charite University, Berlin, Germany
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description neutral oil (vigantol carrier) middle-chain fatty acids (carrier) - Vigantol Cholecalciferol -
- Primary Outcome Measures
Name Time Method wheal diameter in the intradermal test after SIT in the comparison between vitamin D and placebo three years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Charité Universitätsmedizin Berlin, Allergy-Centre-Charité, CCM
🇩🇪Berlin, Germany