Scleroderma, Systemic Sclerosis
Conditions
Keywords
calcinosis, pyrophosphate
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTPyrophosphate
50 mg/kg bwt once daily in gelatine capsules.
DIETARY_SUPPLEMENTPlacebo
Glucose in gelatine capsules.
Sponsors
Research Centre for Natural Sciences
University of Debrecen Dept. of Rheumatology
Szeged University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* to meet ACR/ EULAR classification criteria
Exclusion criteria
* severe upper minfestation of SSC * hypo- or hyperthyreoidism * QT prolongation on ECG
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the size of calcinosis nodues. | 52 weeks+ 16 weeks | Volumetric assessment with low energy CT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of the severity of sympthoms caused by calcinosis | 52 weeks+ 16 weeks | Visual analogue scale (0-100) |
| Change of the activity of calcinosis | 52 weeks+ 16 weeks | Visual analogue scale (0-100) |
| Change of the size of calcinosis by ultrasound | 52 weeks+ 16 weeks | Volumetric assessment by ultrasound |
Contacts
Primary ContactLászló Kovács, MD, PhD
Backup ContactMárta Bocskai, MD
Outcome results
None listed