[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"allergic-rhinitis-due-to-grass-pollen\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:allergic-rhinitis-due-to-grass-pollen":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":12,"acronym":13,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100520844",false,"NCT06061848","Intralymphatic Immunotherapy Enhanced by Vitamin-D, a Randomized Placebo-controlled Trial and Comparison With SLIT","ILIT vs SLIT","Inclusion Criteria:\n\n* moderate to severe allergic rhinitis due to grass pollen, with Rhinitis Total Symptom Score \\>\u002F= 8.\n* informed consent\n\nExclusion Criteria:\n\n* chronic rhinosinusitis with or without nose polyps\n* Previous immunotherapy (SLIT or SCIT)\n* BMI \\> 35\n* house dust mite allergy with symptoms\n* allergy towards furry animals if exposition cannot be avoided\n* 25(OH)Vitamin D levels \\\u003C 25 or \\> 75 nmol\u002FL\n* use of Vitamin D supplementation or excessive use of sun tanning booths\n* mental incapacity to follow study protocol\n* other significant disease\n* allergy towards study medication\n* uncontrolled asthma\n* severe atopic dermatitis\n* pregnancy or nursing\n* autoimmune disease\n* hyper IgE-syndrome\n* cardiovascular disease\n* lung disease\n* liver or kidney disease\n* hematologic disorder\n* metabolic disease\n* chronic infectious disese\n* medications interacting with the immune system\n* cancer\n* previous cytostatic therapy\n* medication with beta-blockers or ACE-inhibiters, if medication cannot be paused at the day for treatment\n* drug or alcohol abuse\n* intake of other study product within 1 month or 6 half times, which ever is longest, before visit 1\n* withdrawn consent\n\nExclusion Criteria only for ILIT group (due to vitamin D treatment)\n\n* medication witch can interacts with vitD: (ACE-inhibitors, antiepileptic drugs, glycosides, orlistat, statines, thiazide diuretics)\n* tendency for formation of kidney stones\n* hyperparathyroidism or other disease conferring risk of hypercalcemia\n* hereditary pseudohypoparathyroidism with decreased phosphorous secretion\n* malabsorption or bowel disease with diarrhea\n* Mb Paget, osteoporosis or sarcoidosis\n* skin disease at the groin (where the treatment will be injected)","ALL","18 Years","60 Years",{"count":19,"type":20},360,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE2","PHASE3","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.",[27],"Allergic Rhinitis Due to Grass Pollen","RECRUITING","2024-10-17",{"date":31,"type":32},"2024-10-21","ACTUAL",{"date":34,"type":32},"2023-02-01",{"date":36,"type":20},"2031-12-28",{"name":38,"class":39},"Lars Olaf Cardell","OTHER",3,""]