Hypercalcemia After Paraffin Oil Injection

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-80
SponsorMartin Blomberg Jensen

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Biochemical observational

    Diagnostic test

    no intervention - observational

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Foreign body granuloma1 intervention

Trial outcomes

Primary outcomes

1

Hypercalcemia

the number of men with elevated ionized calcium (above 1.32 mmol/l)

Time frame
determined 2-10 years after paraffin oil injection (first visit)
2

production of 1,25OHD3

production of 1,25OHD3 determined in media from granuloma tissue culture compared with kidney culture by ELISA platform

Time frame
ex vivo culture experiments of human granuloma tissue for 48 to 72 hours

Secondary outcomes

1

hypercalciuria

calcium excretion determined by spot or 24 hour urine

Time frame
determined 2-10 years after paraffin oil injection
2

change in serum 1,25OH2D3

differences in calcitriol production or conversion rate 1,25OH2D3/25OHD that reflects how active the enzyme is

Time frame
determined 2-10 years after paraffin oil injection (first visit)
3

nephrolithiasis

obtained by interview -anamnesis and preferably supported by jorunal of CT report on nephrolithiasis

Time frame
determined 2-10 years after paraffin oil injection (first visit)
4

Overall change in calcium homeostasis

changes in calcium, PTH, alkaline phosphatase and 1,25OHD depending on oil injected, varm/cold

Time frame
determined 2-10 years after paraffin oil injection (first visit)

Other outcomes

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