Last reviewed · How we verify
NCT04292288
Hypercalcemia After Paraffin Oil Injection
trial testing Biochemical observational in Hypercalcemia in 200 participants. Currently enrolling.
1 January 2028
Quick facts
| Lead sponsor | Martin Blomberg Jensen |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 200 |
| Start date | 1 April 2019 |
| Primary completion | 1 January 2028 |
| Estimated completion | 1 January 2029 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Biochemical observational
Conditions studied
- Hypercalcemia — all drugs for Hypercalcemia →
- Granuloma — all drugs for Granuloma →
Sponsor
Martin Blomberg Jensen — full company profile →
Who can join
Adults 18 to 80, male only, with Hypercalcemia or Granuloma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04292288
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hypercalcemia
Currently open trials in the same condition.
- NCT03935984 — Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity · Phase 4 · recruiting
- NCT04265599 — Exploring Pathogenesis and Treatment of Hypercalcemia Caused by Intramuscular Injection of Paraffinoil · recruiting
- NCT05585593 — Registry for Hypoparathyroidism Wuerzburg · recruiting
- NCT06467877 — Causes, Characteristics and Treatment of Hypercalcemia in the Emergency Room of a German Hospital · active not recruiting
Other Martin Blomberg Jensen trials
Trials by the same sponsor.
- NCT06300229 — NAPO - Novel Approach for Oligospermia · Phase 1, PHASE2 · completed
- NCT05212337 — FITMI - First In Treating Male Infertility · Phase 2 · active not recruiting
- NCT03418896 — Extragonadal Effects of hCG on Calcium Homeostasis · Phase 1 · completed
- NCT03254641 — Calciotropic Effects After HCG Stimulation Test · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04292288 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Martin Blomberg Jensen
- Last refreshed: 6 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04292288.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing