Intralymphatic Immunotherapy Enhanced by Vitamin-D, a Randomized Placebo-controlled Trial and Comparison With SLIT

A national, multicenter, randmised double blind study with parallell arms. 360 patients with grass induced allergic rhinitis will be open randomised 1:2 to 3 years Grazax sublingual immunotherapy or 3 intralymphatic injections with ALK Alutard Timothy. In a second step, the ILIT group will be double blind randomised 1:1 to an intramuscular injection of Vitamin D Vicotrat or placebo, 4 week before the start of the intralymphatic treatment. The primary outcome measure is daily combined symptoms and medication scores during grass pollen season.

NCT Number	NCT06061848
Lead Sponsor	Lars Olaf Cardell
Conditions	Allergic Rhinitis Due to Grass Pollen
Enrollment	360 participants
Start Date	2023-02-01
Primary Completion	2030-12-28 (estimated)
Study Completion	2031-12-28 (estimated)
Updated on ClinicalTrials.gov	2024-10-21