Idiopathic Pulmonary Fibrosis (IPF)NCT06909409
D Vitamin and Alveolar Macrophages in Idiopathic Pulmonal Fibrosis
An observational study of Idiopathic Pulmonary Fibrosis (IPF), run by University of Aarhus at 1 site in Denmark.
Trial summary
The goal of this observational study is to gain deeper insights into human macrophages and vitamin D, and their interplay, within Idiopathic Pulmonary Fibrosis (IPF). The overall questions, it aims to answer, are the following: Do IPF patients suffer from systemic and local (pulmonary) insufficient levels of vitamin… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis (IPF)
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- 11 Oct 2024to 11 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients at the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Denmark, diagnosed with ILD or lung cancer.
Who may be able to join
- A clinical diagnosis of IPF, non-IPF ILD or lung cancer
- A signed informed consent
Who cannot join
- Do not speak Danish/Do not understand Danish
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital, Denmark
Aarhus N, 8200
Anne J Nielsen, PhD Student, +45 29611543, anjuni@rm.dk
About this study
The goal of this observational study is to gain deeper insights into human macrophages and vitamin D, and their interplay, within Idiopathic Pulmonary Fibrosis (IPF).
The overall questions, it aims to answer, are the following:
Do IPF patients suffer from systemic and local (pulmonary) insufficient levels of vitamin D? Do IPF patients suffer from pro-fibrotic and pro-inflammatory pulmonary macrophages?
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Keywords
- Idiopathic pulmonary fibrosis, pulmonary macrophages, alveolar macrophages, vitamin D, Soluble CD163, Soluble CD206
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with IPF | Not described | |
| Patients with non-IPF interstitial lung disease (ILD) | Not described | |
| Patients with lung cancer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D status
Significant change in vitamin D levels in systemic (blood) and local (pulmonary) metabolism.
Measured: At enrollment
Pulmonary macrophages
Significant change in alveolar macrophage phenotype
Measured: At enrollment
Secondary outcomes (1)
Biomarker levels in blood and BAL samples
Significant change in levels of macrophage and inflammatory/fibrotic biomarkers
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start11 Oct 2024
- Primary completion11 Oct 2026 (estimated)
- Study completion11 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Fibrosis (IPF)Studies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909409
- Sponsor's protocol ID
- 1-10-72-166-23
- Status last verified
- Oct 2024
- First submitted
- 27 Mar 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- D Vitamin and Alveolar Macrophages in Idiopathic Pulmonal Fibrosis
- ClinicalTrials.gov ID
- NCT06909409
- Acronym / sponsor ID
- 1-10-72-166-23
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Keywords
- Idiopathic pulmonary fibrosis, pulmonary macrophages, alveolar macrophages, vitamin D, Soluble CD163, Soluble CD206
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 11 Oct 2024 (actual)
- Primary completion
- 11 Oct 2026 (estimated)
- Study completion
- 11 Oct 2026 (estimated)
- First posted
- 3 Apr 2025 (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 goal of this observational study is to gain deeper insights into human macrophages and vitamin D, and their interplay, within Idiopathic Pulmonary Fibrosis (IPF).
The overall questions, it aims to answer, are the following:
Do IPF patients suffer from systemic and local (pulmonary) insufficient levels of vitamin D? Do IPF patients suffer from pro-fibrotic and pro-inflammatory pulmonary macrophages?
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with IPF | – | – |
| Patients with non-IPF interstitial lung disease (ILD) | – | – |
| Patients with lung cancer | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Denmark, diagnosed with ILD or lung cancer.
Key inclusion criteria (2 listed)
- A clinical diagnosis of IPF, non-IPF ILD or lung cancer
- A signed informed consent
Key exclusion criteria (1 listed)
- Do not speak Danish/Do not understand Danish
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
Vitamin D status
Time frame: At enrollment
Significant change in vitamin D levels in systemic (blood) and local (pulmonary) metabolism.
Pulmonary macrophages
Time frame: At enrollment
Significant change in alveolar macrophage phenotype
1 secondary outcome
Biomarker levels in blood and BAL samples
Time frame: At enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
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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. This study is not recruiting at the moment.
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 Idiopathic Pulmonary Fibrosis (IPF), run by University of Aarhus 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 2 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: status not confirmed, as of the sponsor's last update on 3 Apr 2025. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin D status (time frame: At enrollment). 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 3 Apr 2025.