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NCT Number: NCT04265599

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

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.

Recruiting

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Key information

Conditions

Hypercalcemia Calcium Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Paraffinoma Renal Injury Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • previous intramuscular injection of paraffin or other oil

Exclusion criteria

  • none

Treatment and study plan

Primary outcomes

  1. Number of patients with concentration of ionized calcium in plasma above normal range = Hypercalcemia

    Time frame: at first examination or developed during observation period until 2025

    Hypercalcemia in plasma (exploratory not intervention study). yes or no and level.

  2. Number of patients with concentration of parathyroid hormone PTH in plasma below normal range

    Time frame: at first examination or developed during observation period until 2025

    PTH level in plasma indicator of hypercalcemia

Study contacts

Contact information is provided by the study sponsor or research team.

Ebbe Eldrup, DMSc

CONTACT

[email protected]

800-045-3868

Martin Blomberg Jensen, DMSc

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Registry information

Official study title

Hypercalcemia After Cosmetic Paraffin Oil Injections: Unravelling Etiology, Pathogenesis and Potential Treatments

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Feb 11, 2020
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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