Cathelicidin and Vitamin D: Impact on Populations At-Risk and With COPD

NCT02464059 | Completed Phase 2 Results

• 1 other identifier: 16-2200
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

Brief Summary

This proposal will evaluate a potential mechanism of increased risk of lung function impairment, cathelicidin levels, as well as determine if vitamin D replacement can alter this pathway. This study will improve the understanding of factors which can lead to chronic lung disease. If effective, this application would also provide the justification to study vitamin D as a therapy to improve lung health.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Cathelicidin; Vitamin D

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Lung Cathelicidin Level at 8 Weeks

  Change from baseline to 8 weeks in bronchoscopic lavage lung cathelicidin levels after vitamin D supplementation (comparison between pre- and post-supplementation cathelicidin levels using paired t-tests for repeated measures)

  Baseline and 8 weeks

Secondary Outcomes (2)

• Change From Baseline in Blood Cathelicidin at 8 Weeks

  Baseline and 8 weeks

• Change From Baseline in Blood Vitamin D Binding Protein at 8 Weeks

  Baseline and 8 weeks

Study Arms (1)

Vitamin D3

EXPERIMENTAL

Oral supplementation with 50,000 IU vitamin D3 weekly for eight weeks

Drug: Vitamin D3

Interventions

Vitamin D3 DRUG

Oral supplementation with 50,000 IU vitamin D3 weekly for eight weeks in individuals with reduced vitamin D levels.

Also known as: cholecalciferol

Vitamin D3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women age 18-65 who are current or former smokers
• Serum calcium\<10.5mg/dL
• Hydroxy Vitamin D (OHD)\<20 ng/mL
• Creatinine Clearance ≥60 mL/min as estimated by the Cockcroft-Gault equation
• Women of reproductive potential with negative serum or urine pregnancy test and subjects must refrain from participating in a conception process and subject/partner must use at least 2 reliable forms of contraceptives for the duration of the study
• For participants with COPD, Forced Expiratory Volume in 1 second (FEV1) greater than 50% predicted.
• For smokers, current cigarette use (defined as regularly smoking 5 cigarettes per day)

You may not qualify if:

• Current use of vitamin D supplements
• Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulations
• Pregnancy or currently breast-feeding
• History of nephrolithiasis
• HIV positive serostatus
• Continuous oxygen use \>2 liters/min via nasal cannula
• Any condition that, in the opinion of the site investigator, would compromise the subject's ability to participate in the study.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Johns Hopkins University: collaborator

Study Sites (2)

Johns Hopkins Clinical Research Unit

Baltimore, Maryland, 21224, United States

Location

Meadowmont Pulmonary Research Clinic

Chapel Hill, North Carolina, 27517, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Limitations and Caveats

Study enrollment did not achieve targeted sample size enrollment during the time frame of the funding award.

Results Point of Contact

• Title: Michael Bradley Drummond, MD
• Organization: University of North Carolina at Chapel Hill

brad_drummond@med.unc.edu

919-966-7054

Study Officials

• Michael B Drummond, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: June 8, 2015
• Study Start: November 10, 2015
• Primary Completion: April 15, 2020
• Study Completion: April 15, 2020
• Last Updated: July 24, 2020
• Results First Posted: July 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)