[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520844":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":41,"centralContacts":45,"locations":55,"responsibleParty":99,"collaborators":30,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":105,"sex":110,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":30,"studyType":116,"phases":117,"briefSummary":120,"conditions":121,"keywords":30,"overallStatus":86,"whyStopped":30,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Karolinska Institutet","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"SLIT","ACTIVE_COMPARATOR","Sublingual immunotherapy timothy pollen 75000 SQ-T 1 daily for 3 years",[13],"Drug: SLIT Grazax ALK Nordic 75 000 SQ-T",{"label":15,"type":10,"description":16,"interventionNames":17},"ILIT + Vitamin D","Intramuscular injection of kolecalciferol 100000 IU followed by intralymphatic immunotherapy with 3 monthly injections of grass pollen allergen 1000 SQ-U.",[18],"Drug: ILIT + Vitamin D",{"label":20,"type":10,"description":21,"interventionNames":22},"ILIT + placebo","Intramuscular injection of saline solution followed by intralymphatic immunotherapy with 3 monthly injections of grass pollen allergen 1000 SQ-U.",[23],"Drug: ILIT + placebo",[25,31,36],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","SLIT Grazax ALK Nordic 75 000 SQ-T","Daily sublingual grass allergen tablets",[9],null,{"type":26,"name":15,"description":32,"armGroupLabels":33,"otherNames":34},"1 mL of Vicotrat D3, Heyl Pharma, 100 000 IU\u002FmL, as intramuscular injection. Followed by 0,1 mL of Alutard SQ timothy, ALK Nordic, 10 000 SQ-U\u002FmL as three intralymphatic injections",[15],[35],"Alutard SQ timothy and Vicotrat D3",{"type":26,"name":20,"description":37,"armGroupLabels":38,"otherNames":39},"1 ml of Sodium chloride solution 9 mg\u002FmL as intramuscular injection followed by 0,1 mL of Alutard SQ timothy, ALK Nordic, 10 000 SQ-U\u002FmL as three intralymphatic injections",[20],[40],"Alutard SQ timothy and Sodium chloride",[42],{"name":43,"affiliation":5,"role":44},"Lars O Cardell, Professor","PRINCIPAL_INVESTIGATOR",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":30,"email":50},"Agneta Karlsson, Study nurse","CONTACT","+46 72 580 29 63","agneta.j.karlsson@regionstockholm.se",{"name":52,"role":48,"phone":53,"phoneExt":30,"email":54},"Laila Hellkvist, MD, PhD","+46 72 469 46 07","laila.hellkvist@regionstockholm.se",[56,72,84],{"facility":57,"status":58,"city":59,"state":30,"zip":30,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Skåne University Hospital, ENT department","NOT_YET_RECRUITING","Lund","Sweden","SE",{"type":63,"coordinates":64},"Point",[65,66],13.19321,55.70584,{"lat":66,"lon":65},[69],{"name":70,"role":48,"phone":30,"phoneExt":30,"email":71},"Franziska Nordström, MD","franziska.nordstrom@skane.se",{"facility":73,"status":58,"city":74,"state":30,"zip":30,"country":60,"countryCode":61,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Örebro University Hospital","Örebro",{"type":63,"coordinates":76},[77,78],15.2066,59.27412,{"lat":78,"lon":77},[81],{"name":82,"role":48,"phone":30,"phoneExt":30,"email":83},"Amanj Saber, MD","amanj.saber@regionorebrolan.se",{"facility":85,"status":86,"city":87,"state":30,"zip":30,"country":60,"countryCode":61,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Karolinska University Hospital, ENT-department","RECRUITING","Stockholm",{"type":63,"coordinates":89},[90,91],18.06871,59.32938,{"lat":91,"lon":90},[94,98],{"name":95,"role":48,"phone":96,"phoneExt":30,"email":97},"Eirini Paziou, MD","+46 8 123 723 96","eirini.paziou@regionstockholm.se",{"name":52,"role":48,"phone":53,"phoneExt":30,"email":54},{"type":100,"investigatorFullName":101,"investigatorTitle":102,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"SPONSOR_INVESTIGATOR","Lars Olaf Cardell","Professor","100520844","phase-2-intralymphatic-immunotherapy-enhanced-by-vitamin-d-a-randomized-placebo-controlled-trial-and-comparison-with-slit-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":114,"type":115},360,"ESTIMATED","INTERVENTIONAL",[118,119],"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.",[122],"Allergic Rhinitis Due to Grass Pollen","2024-10-17",{"date":125,"type":126},"2024-10-21","ACTUAL",{"date":128,"type":126},"2023-02-01",{"date":130,"type":115},"2031-12-28",{"name":101,"class":6},3]