HypercalcemiaNCT04265599
Exploring Pathogenesis and Treatment of Hypercalcemia Caused by Intramuscular Injection of Paraffinoil
An observational study of Hypercalcemia and Renal Injury, run by Herlev Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercalcemia, Renal Injury, Paraffinoma
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Apr 2019to 31 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: General population
Who may be able to join
- previous intramuscular injection of paraffin or other oil
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Martin Blomberg Jensen, DMSc contact
Denmark1 site, 1 recruiting
- Recruiting
Herlev Hospital
Copenhagen
Ebbe Eldrup, DMSc, +45 38681154, ebbe.eldrup@regionh.dk
Martin Blomberg Jensen, DMSc, blombergjensen@gmail.com
About this study
Official title: Hypercalcemia After Cosmetic Paraffin Oil Injections: Unravelling Etiology, Pathogenesis and Potential Treatments
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.
- Conditions
- Hypercalcemia, Renal Injury, Paraffinoma
- Medical subject headings
- Hypercalcemia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at first examination or developed during observation period until 2025
Number of patients with concentration of parathyroid hormone PTH in plasma below normal range
PTH level in plasma indicator of hypercalcemia
Measured: at first examination or developed during observation period until 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start30 Apr 2019
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercalcemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebbe Eldrup, MD, DMSc, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265599
- Sponsor's protocol ID
- VEK RegionH: H-19010297
- Status last verified
- Sep 2024
- First submitted
- 7 Feb 2020
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypercalcemia After Cosmetic Paraffin Oil Injections: Unravelling Etiology, Pathogenesis and Potential Treatments
- ClinicalTrials.gov ID
- NCT04265599
- Acronym / sponsor ID
- VEK RegionH: H-19010297
- Conditions
- Hypercalcemia, Renal Injury, Paraffinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General population
Key inclusion criteria (1 listed)
- previous intramuscular injection of paraffin or other oil
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martin Blomberg Jensen, DMSc contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercalcemia and Renal Injury, run by Herlev Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ebbe Eldrup, DMSc (800-045-3868, ebbe.eldrup@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.