NCT04292288

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
33mo left

Started Apr 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Apr 2019Jan 2029

Study Start

First participant enrolled

April 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2019

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 3, 2020

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

April 6, 2025

Status Verified

April 1, 2025

Enrollment Period

8.8 years

First QC Date

September 26, 2019

Last Update Submit

April 2, 2025

Conditions

HypercalcemiaGranuloma

Outcome Measures

Primary Outcomes (2)

  • Hypercalcemia

    the number of men with elevated ionized calcium (above 1.32 mmol/l)

    determined 2-10 years after paraffin oil injection (first visit)

  • production of 1,25OHD3

    production of 1,25OHD3 determined in media from granuloma tissue culture compared with kidney culture by ELISA platform

    ex vivo culture experiments of human granuloma tissue for 48 to 72 hours

Secondary Outcomes (11)

  • hypercalciuria

    determined 2-10 years after paraffin oil injection

  • change in serum 1,25OH2D3

    determined 2-10 years after paraffin oil injection (first visit)

  • nephrolithiasis

    determined 2-10 years after paraffin oil injection (first visit)

  • Overall change in calcium homeostasis

    determined 2-10 years after paraffin oil injection (first visit)

  • inflammatory response

    determined 2-10 years after paraffin oil injection (first visit)

  • +6 more secondary outcomes

Study Arms (1)

Foreign body granuloma

men injecting paraffin oil

Diagnostic Test: Biochemical observational

Interventions

Biochemical observationalDIAGNOSTIC_TEST

no intervention - observational

Foreign body granuloma

Eligibility Criteria

Age18 Years - 80 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsno females
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Up to 200 people (predominantly men) \<80 years will be included. Inclusion takes place at Endocrinological Section, Medical Department O, Herlev Hospital in connection with an outpatient visit. After initial discussions, reflection time and acceptance of participation in the study, extended blood tests are taken in connection with the pre-planned outpatient visits.

You may not qualify if:

  • incurable cancer disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev Hospital

Herlev, Denmark

RECRUITING

MeSH Terms

Conditions

HypercalcemiaGranuloma

Condition Hierarchy (Ancestors)

Calcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesWater-Electrolyte ImbalanceLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ebbe Eldrup

    Herlev

    STUDY CHAIR

Central Study Contacts

Martin Blomberg Jensen

CONTACT

+4535453545blombergjensen@gmail.com

Ebbe Eldrup

CONTACT

+4538683868Ebbe.Eldrup@regionh.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Group leader

Study Record Dates

First Submitted

September 26, 2019

First Posted

March 3, 2020

Study Start

April 1, 2019

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2029

Last Updated

April 6, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)