Actively Recruiting
Intralymphatic Immunotherapy Enhanced by Vitamin-D, a Randomized Placebo-controlled Trial and Comparison With SLIT
Led by Lars Olaf Cardell · Updated on 2024-10-21
360
Participants Needed
3
Research Sites
464 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intralymphatic Immunotherapy Enhanced by Vitamin-D, a Randomized Placebo-controlled Trial and Comparison With SLIT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Moderate to severe allergic rhinitis due to grass pollen, with Rhinitis Total Symptom Score ≥ 8
- Provided informed consent
- Aged 18 to 60 years
You will not qualify if you...
- Chronic rhinosinusitis with or without nasal polyps
- Previous immunotherapy (SLIT or SCIT)
- Body mass index over 35
- Symptomatic house dust mite allergy
- Allergy to furry animals if exposure cannot be avoided
- Vitamin D levels less than 25 or greater than 75 nmol/L
- Use of Vitamin D supplements or excessive tanning booth use
- Mental incapacity to follow study protocol
- Other significant diseases
- Allergy to study medications
- Uncontrolled asthma
- Severe atopic dermatitis
- Pregnancy or nursing
- Autoimmune disease
- Hyper IgE syndrome
- Cardiovascular disease
- Lung disease
- Liver or kidney disease
- Hematologic disorders
- Metabolic diseases
- Chronic infectious diseases
- Medications interacting with the immune system
- Cancer
- Previous cytostatic therapy
- Use of beta-blockers or ACE inhibitors if cannot pause on treatment day
- Drug or alcohol abuse
- Intake of other study products within 1 month or 6 half-lives before visit 1
- Withdrawn consent
- For ILIT group only: Medications interacting with Vitamin D (ACE inhibitors, antiepileptic drugs, glycosides, orlistat, statins, thiazide diuretics)
- Tendency to form kidney stones
- Hyperparathyroidism or risk of hypercalcemia
- Hereditary pseudohypoparathyroidism
- Malabsorption or bowel disease with diarrhea
- Paget's disease, osteoporosis, or sarcoidosis
- Skin disease at the groin injection site
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Skåne University Hospital, ENT department
Lund, Sweden
Not Yet Recruiting
2
Örebro University Hospital
Örebro, Sweden
Not Yet Recruiting
3
Karolinska University Hospital, ENT-department
Stockholm, Sweden
Actively Recruiting
Research Team
A
Agneta Karlsson, Study nurse
CONTACT
L
Laila Hellkvist, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here