D Vitamin and Alveolar Macrophages in Idiopathic Pulmonal Fibrosis

NCT06909409 | Recruiting DMC

• 1 other identifier: 1-10-72-166-23
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (2)

• Vitamin D status

  Significant change in vitamin D levels in systemic (blood) and local (pulmonary) metabolism.

  At enrollment

• Pulmonary macrophages

  Significant change in alveolar macrophage phenotype

  At enrollment

Secondary Outcomes (1)

• Biomarker levels in blood and BAL samples

  At enrollment

Study Arms (3)

Patients with IPF

Patients with non-IPF interstitial lung disease (ILD)

Patients with lung cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Do not speak Danish/Do not understand Danish

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital, Denmark

Aarhus N, 8200, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood: Serum and EDTA-plasma. Bronchoalveolar lavage fluid (BALf). Cryobiopsy.

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 3, 2025
• Study Start: October 11, 2024
• Primary Completion (Estimated): October 11, 2026
• Study Completion (Estimated): October 11, 2026
• Last Updated: April 3, 2025

Record last verified: 2024-10

Locations

DK (1)