Actively Recruiting
Hypercalcemia After Paraffin Oil Injection: Aetiology, Pathogenesis and Possible Treatment Options
Led by Martin Blomberg Jensen · Updated on 2025-04-06
200
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
M
Martin Blomberg Jensen
Lead Sponsor
H
Herlev Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying young men who have injected large amounts of paraffin oil into their muscles in areas like the upper arms and chest to increase muscle size. This practice may cause serious health problems such as foreign body reactions, granuloma formation, and persistent high calcium levels in the blood (hypercalcemia). The study aims to identify risk factors, understand how the disease develops, and explore potential treatments by examining tissue samples from affected patients. The study involves observing men who have injected between 100 and 10,000 ml of paraffin oil. Selected patients' granuloma tissue will be cultured outside the body to test for production of activated vitamin D and other factors that may cause hypercalcemia. Researchers will also test various drugs on these tissues to find the most effective ways to lower calcium levels. The goal is to classify patients based on the severity of their calcium imbalance, which may guide future treatment trials. Participants will be evaluated 2 to 10 years after their paraffin oil injection. The study includes measuring blood calcium levels, kidney function, bone health, inflammation, and other factors related to calcium regulation. Tests involve blood and urine analysis, tissue culture experiments, and clinical assessments. This process helps researchers better understand the disease and develop potential treatment strategies. The total study duration varies per participant based on their history and condition.
CONDITIONS
Brief Title
Hypercalcemia After Paraffin Oil Injection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Previous injection of paraffin oil into the body
You will not qualify if you...
- Inability to walk
- Inability to understand the consequences of inclusion
- Incurable cancer disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single visit
Participants undergo biochemical observational assessments to evaluate calcium homeostasis and related markers several years after paraffin oil injection.
1 visit (in-person)
Duration - 2 to 10 years
Participants are observed over time to monitor changes in calcium homeostasis, kidney function, and inflammatory responses related to granuloma formation.
Follow-up visits may occur depending on individual assessment needs
Trial Site Locations
Total: 1 location
1
Herlev Hospital
Herlev, Denmark
Actively Recruiting
Research Team
M
Martin Blomberg Jensen
E
Ebbe Eldrup
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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