D Vitamin and Alveolar Macrophages in Idiopathic Pulmonal... | NCT06909409

Studies
D Vitamin and Alveolar Macrophages in Idiopathic Pulmonal Fibrosis

NCT06909409

Sponsor

University of Aarhus

Status

Recruiting

Last Update Posted

Apr 3, 2025Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 11, 2024Actual

Primary Completion Date

Oct 11, 2026Estimated

Completion Date

Oct 11, 2026Estimated

First Submitted Date

Mar 27, 2025

First Submission Date that Met QC Criteria

Mar 27, 2025

First Posted Date

Apr 3, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2025

Last Update Posted Date

Apr 3, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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?

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

120Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital, Denmark	Recruiting	Aarhus N		8200	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D054990	Idiopathic Pulmonary Fibrosis

Ancestor Terms

ID	Term
D011658	Pulmonary Fibrosis
D017563	Lung Diseases, Interstitial
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
Patients with IPF
Patients with non-IPF interstitial lung disease (ILD)
Patients with lung cancer