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Hypercalcemia After Paraffin Oil Injection

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Notable Primary completion date: Jan 1, 2026 to Jan 1, 2028
    • Study completion date: Jan 1, 2028 to Jan 1, 2029
    v5
  2. Notable Primary completion date: Jan 1, 2024 to Jan 1, 2026
    • Study completion date: Jan 1, 2025 to Jan 1, 2028
    v4
  3. Notable Primary completion date: Jan 1, 2022 to Jan 1, 2024
    • Study completion date: Jan 1, 2022 to Jan 1, 2025
    v3
  4. Minor Eligibility criteria expanded, about 1 wordv2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT04292288
Lead Sponsor Martin Blomberg Jensen
Collaborators: Herlev Hospital
Conditions
(from sponsor)
Hypercalcemia, Granuloma
Related terms Granuloma, Hypercalcemia
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov