[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100436680":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":31,"studyPopulation":22,"armGroups":32,"interventions":45,"overallOfficials":53,"centralContacts":61,"locations":22,"responsibleParty":71,"collaborators":74,"id":80,"slug":22,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":22,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":22,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":102,"whyStopped":22,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":22},{"fullName":5,"class":6},"Szeged University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"Change in the size of calcinosis nodues.","Volumetric assessment with low energy CT","52 weeks+ 16 weeks",[14,17,19],{"measure":15,"description":16,"timeFrame":12},"Change of the severity of sympthoms caused by calcinosis","Visual analogue scale (0-100)",{"measure":18,"description":16,"timeFrame":12},"Change of the activity of calcinosis",{"measure":20,"description":21,"timeFrame":12},"Change of the size of calcinosis by ultrasound","Volumetric assessment by ultrasound",null,{"allocation":24,"interventionModel":25,"interventionModelDescription":22,"primaryPurpose":26,"observationalModel":22,"timePerspective":22,"maskingInfo":27},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":28,"maskingDescription":22,"whoMasked":29},"SINGLE",[30],"INVESTIGATOR","Calcinosis, the formation of hydroxyapatite subcutaneous nodules, often complicates systemic sclerosis. There is no standard treatment for it. Based upon our preclinical experienc, we would like to test it orally administered pyrophosphate inhibits calciosis.",[33,39],{"label":34,"type":35,"description":36,"interventionNames":37},"Pyrophosphate","EXPERIMENTAL","Disodium pyrophosphate",[38],"Dietary Supplement: Pyrophosphate",{"label":40,"type":41,"description":42,"interventionNames":43},"Placebo","PLACEBO_COMPARATOR","Glucose",[44],"Dietary Supplement: Placebo",[46,50],{"type":47,"name":34,"description":48,"armGroupLabels":49,"otherNames":22},"DIETARY_SUPPLEMENT","50 mg\u002Fkg bwt once daily in gelatine capsules.",[34],{"type":47,"name":40,"description":51,"armGroupLabels":52,"otherNames":22},"Glucose in gelatine capsules.",[40],[54,57],{"name":55,"affiliation":5,"role":56},"László Kovács, MD, Ph.D.","PRINCIPAL_INVESTIGATOR",{"name":58,"affiliation":59,"role":60},"András Váradi, PhD, DSc","Department of Enzymology, Research Centre for Natural Sciences","STUDY_DIRECTOR",[62,67],{"name":63,"role":64,"phone":65,"phoneExt":22,"email":66},"László Kovács, MD, PhD","CONTACT","+36309081611","kovacs.laszlo@med.u-szeged.hu",{"name":68,"role":64,"phone":69,"phoneExt":22,"email":70},"Márta Bocskai, MD","+3662341520","bocskai.marta@med.u-szeged.hu",{"type":56,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"László Kovács MD, PhD","Professor",[75,77],{"name":76,"class":6},"Research Centre for Natural Sciences",{"name":78,"class":79},"University of Debrecen Dept. of Rheumatology","UNKNOWN","100436680",false,"NCT04966416","Calcinosis Reduction by Pyrophosphate in SSC","The Effect of Orally Administered Pyrophosphate on Calcinosis Formation in Systematic Sclerosis","Inclusion Criteria:\n\n* to meet ACR\u002F EULAR classification criteria\n\nExclusion Criteria:\n\n* severe upper minfestation of SSC\n* hypo- or hyperthyreoidism\n* QT prolongation on ECG","ALL","18 Years","70 Years",{"count":90,"type":91},60,"ESTIMATED","INTERVENTIONAL",[94],"NA","Calcinosis, i.e. crystal-like nodules are troublesome complication of systemic sclerosis, an autoimmune disease. Pyrophosphate inhibits its formation is laborytory. We would like to test if orally administered pyrophosphate prevents calcinosis formation.",[97,98],"Systemic Sclerosis","Scleroderma",[100,101],"calcinosis","pyrophosphate","NOT_YET_RECRUITING","2023-05-23",{"date":105,"type":106},"2023-05-25","ACTUAL",{"date":108,"type":91},"2023-08-01",{"date":110,"type":91},"2026-06-30",{"name":5,"class":6}]