D Vitamin and Alveolar Macrophages in Idiopathic Pulmonal Fibrosis

March 27, 2025 updated by: University of Aarhus

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus N, Denmark, 8200
        • Recruiting
        • Aarhus University Hospital, Denmark
        • Contact:
          • Anne J Nielsen, PhD Student
          • Phone Number: +45 29611543
          • Email: anjuni@rm.dk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients at the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Denmark, diagnosed with ILD or lung cancer.

Description

Inclusion Criteria:

  • A clinical diagnosis of IPF, non-IPF ILD or lung cancer
  • A signed informed consent

Exclusion Criteria:

  • Do not speak Danish/Do not understand Danish

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with IPF
Patients with non-IPF interstitial lung disease (ILD)
Patients with lung cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vitamin D status
Time Frame: At enrollment
Significant change in vitamin D levels in systemic (blood) and local (pulmonary) metabolism.
At enrollment
Pulmonary macrophages
Time Frame: At enrollment
Significant change in alveolar macrophage phenotype
At enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarker levels in blood and BAL samples
Time Frame: At enrollment
Significant change in levels of macrophage and inflammatory/fibrotic biomarkers
At enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2024

Primary Completion (Estimated)

October 11, 2026

Study Completion (Estimated)

October 11, 2026

Study Registration Dates

First Submitted

March 27, 2025

First Submitted That Met QC Criteria

March 27, 2025

First Posted (Actual)

April 3, 2025

Study Record Updates

Last Update Posted (Actual)

April 3, 2025

Last Update Submitted That Met QC Criteria

March 27, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-10-72-166-23

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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