Calcinosis Reduction by Pyrophosphate in SSC
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSzeged University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
to meet ACR/ EULAR classification criteria
Disqualifiers
severe upper minfestation of SSC
hypo- or hyperthyreoidism
QT prolongation on ECG
Trial design
Design model
Parallel
Treatments tested in this trial
Pyrophosphate
Dietary supplement50 mg/kg bwt once daily in gelatine capsules.
Placebo
Dietary supplementGlucose in gelatine capsules.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: PyrophosphateExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in the size of calcinosis nodues.
Volumetric assessment with low energy CT
Time frame
52 weeks+ 16 weeksSecondary outcomes
1
Change of the severity of sympthoms caused by calcinosis
Visual analogue scale (0-100)
Time frame
52 weeks+ 16 weeks2
Change of the activity of calcinosis
Visual analogue scale (0-100)
Time frame
52 weeks+ 16 weeks3
Change of the size of calcinosis by ultrasound
Volumetric assessment by ultrasound
Time frame
52 weeks+ 16 weeksLocations
Sponsors and contacts
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Szeged University
Lead sponsor
Research Centre for Natural Sciences
Collaborator
University of Debrecen Dept. of Rheumatology
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: