Exploring Pathogenesis and Treatment of Hypercalcemia Caused by Intramuscular Injection of Paraffinoil

Recruiting

• Conditions: Paraffinoma; Hypercalcemia; Renal Injury

• Registration Number: NCT04265599
• Lead Sponsor: Herlev Hospital

Brief Summary

The aim of the study is to characterize paraffin oil induced granulomatous disease. We will investigate pathogenesis and natural history of paraffin disease. Subsequently, through further translational studies, we intend to identify novel treatments to be tested in future randomized clinical trials.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-30
• Study First Submitted: 2020-02-07
• Study First Submitted QC: 2020-02-10
• Study First Posted: 2020-02-11
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-01
• Primary Completion: 2027-01-31
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• previous intramuscular injection of paraffin or other oil

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with concentration of parathyroid hormone PTH in plasma below normal range	at first examination or developed during observation period until 2025	PTH level in plasma indicator of hypercalcemia
Number of patients with concentration of ionized calcium in plasma above normal range = Hypercalcemia	at first examination or developed during observation period until 2025	Hypercalcemia in plasma (exploratory not intervention study). yes or no and level.

Trial Locations

Locations (1)

Herlev Hospital; 🇩🇰 Copenhagen, Denmark