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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04265599
Other study ID # VEK RegionH: H-19010297
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 30, 2019
Est. completion date January 31, 2025

Study information

Verified date August 2021
Source Herlev Hospital
Contact Ebbe Eldrup, DMSc
Phone +45 38681154
Email ebbe.eldrup@regionh.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date January 31, 2025
Est. primary completion date January 31, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - previous intramuscular injection of paraffin or other oil Exclusion Criteria: - none

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Denmark Herlev Hospital Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

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