Ignite Creation Date:
2024-05-06 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06061848
Status:
RECRUITING
Last Update Posted:
2023-11-29
First Post:
2023-09-11
Brief Title:
Intralymphatic Immunotherapy Enhanced by Vitamin-D a Randomized Placebo-controlled Trial and Comparison With SLIT
Sponsor:
Lars Olaf Cardell
Organization:
Karolinska Institutet
Study Overview
Official Title:
Intralymphatic Immunotherapy Enhanced by Vitamin-D a Randomized Placebo-controlled Trial and Comparison With SLIT
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ILIT vs SLIT
Brief Summary:
A national multicenter randmised double blind study with parallell arms 360 patients with grass induced allergic rhinitis will be open randomised 12 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 11 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None