DBPC-Dose-finding-trial of Vitamin D3 for SCIT in Birch Pollen Allergic Patients.
Status:
Completed
Trial end date:
2016-10-01
Target enrollment:
Participant gender:
Summary
Low Vitamin D3 (VD3) levels have been reported to be associated with the risk of allergic
diseases like asthma. VD3 has been demonstrated in vitro, ex vivo and in animal models to
program the immune system towards anti-inflammatory immune responses. VD3 co-administered
with allergen may be a promising adjuvant to improve the onset and efficacy of allergen
immunotherapy (AIT). A clinical trial will be performed to compare the immune effects, the
tolerability and safety of multiple doses of aVD3 analogue (registered for the intravenous
route) administered by the subcutaneous (s.c.) route in subjects with allergic rhinitis and
healthy controls.
The overall aim is to provide additional (in vivo) support for the use of VD3 as an adjuvant
in allergen-specific immunotherapy, on top of the existing pre-clinical evidence
demonstrating that antigen-presenting cells educate the adaptive immune system towards an
anti-inflammatory response when allergen is seen in the presence of VD3.
Phase:
Phase 2
Details
Lead Sponsor:
Laurian Jongejan
Treatments:
Cholecalciferol Ergocalciferols Vitamin D Vitamins