About this trial
Today, there is an increased use of non-medical, invasive cosmetic treatments globally without sufficient awareness of possible health risks. A particular problem is young men injecting large amounts of paraffin oil into skeletal muscles especially on upper arms and chest to increase the visible size of the muscles. Several case reports have suggested that intramuscular injection of paraffin oil induces foreign body reaction and granuloma formation and subsequently hypercalcemia. Our hypothesis is that increased generation of activated vitamin D (1,25(OH)2D3) in the marcrophages may be responsible for the persistent hypercalcemia. Now trhe investigators want to include a large group of men who injected 100-10.000 ml paraffin oil to identify risk factors for developing hypercalcemia and try to understand the pathogenesis of the disease. Additionally, granuloma tissue from selected patients will be cultured ex vivo to investigate whether they produce 1,25(OH)2D3 or PTHrP and to test which drugs can most effectively be used to lower calcium levels in these men. Subsequently, we will try to stratify the men according to the severity of the changes in calcium homeostasis as we suggest that this stratification will be the basis for future intervention trials
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
previous injection of paraffin oil into the body
Disqualifiers
inability to walk
inability to understand the consequences of inclusion
incurable cancer disease
Trial population
Up to 200 people (predominantly men) \<80 years will be included. Inclusion takes place at Endocrinological Section, Medical Department O, Herlev Hospital in connection with an outpatient visit. After initial discussions, reflection time and acceptance of participation in the study, extended blood tests are taken in connection with the pre-planned outpatient visits.
Trial design
Cohort
Prospective
Treatments tested in this trial
Biochemical observational
Diagnostic testno intervention - observational
Treatment groups
Trial outcomes
Primary outcomes
Hypercalcemia
the number of men with elevated ionized calcium (above 1.32 mmol/l)
production of 1,25OHD3
production of 1,25OHD3 determined in media from granuloma tissue culture compared with kidney culture by ELISA platform
Secondary outcomes
hypercalciuria
calcium excretion determined by spot or 24 hour urine
change in serum 1,25OH2D3
differences in calcitriol production or conversion rate 1,25OH2D3/25OHD that reflects how active the enzyme is
nephrolithiasis
obtained by interview -anamnesis and preferably supported by jorunal of CT report on nephrolithiasis
Overall change in calcium homeostasis
changes in calcium, PTH, alkaline phosphatase and 1,25OHD depending on oil injected, varm/cold
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Martin Blomberg Jensen
Lead sponsor
Rigshospitalet, Denmark
Sponsor institution
Herlev Hospital
Collaborator