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

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ClinicalTrials.gov Identifier: NCT02464059
Recruitment Status : Enrolling by invitation
First Posted : June 8, 2015
Last Update Posted : October 25, 2017
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Michael (Brad) Drummond, MD, MHS, University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: Vitamin D3 Phase 2

Detailed Description:
Understanding mechanisms leading to decrements in lung function, the physiologic hallmark of obstructive lung diseases including chronic obstructive pulmonary disease (COPD), are necessary to inform interventions to improve lung health. The antimicrobial peptide cathelicidin, and its primary regulator vitamin D, has been implicated in development and progression of chronic lung disease. In this study, the investigators will evaluate the effect of oral vitamin D supplementation on lung cathelicidin levels in humans. Cathelicidin has bactericidal and inflammatory activities in the lung and is regulated by vitamin D levels. The investigators hypothesize that oral vitamin D supplementation will raise cathelicidin levels in the pulmonary compartment, thereby restoring lung cathelicidin deficiency. To test this hypothesis, the investigators will recruit from two ongoing cohort studies: 1) At Johns Hopkins, the Subpopulations and Intermediate Outcome Measures in COPD Study study and 2)at University of North Carolina at Chapel Hill pulmonary and general medicine clinic. The investigators will measure blood and lung lavage cathelicidin levels in 40 vitamin D insufficient individuals (20 from each cohort) before and after eight weeks of oral vitamin D supplementation to determine the effect of vitamin D supplementation on cathelicidin levels.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Cathelicidin and Vitamin D: Impact on Populations At-Risk and With COPD
Study Start Date : June 2015
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Experimental: Vitamin D3
Oral supplementation with 50,000 IU vitamin D3 weekly for eight weeks
Drug: Vitamin D3
The design of the study to complete this aim will be in the format of a baseline and repeat bronchoscopy after oral supplementation with 50,000 IU vitamin D3 weekly for eight weeks in individuals with reduced vitamin D levels.
Other Name: cholecalciferol




Primary Outcome Measures :
  1. Change from baseline in lung cathelicidin level at 8 weeks [ Time Frame: Baseline and 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)


Secondary Outcome Measures :
  1. Change from baseline in blood cathelicidin at 8 weeks [ Time Frame: Baseline and 8 weeks ]
    Change from baseline to 8 weeks in blood cathelicidin levels after vitamin D supplementation (comparison between pre- and post-supplementation cathelicidin levels using paired t-tests for repeated measures)

  2. Change from baseline in blood vitamin D binding protein at 8 weeks [ Time Frame: Baseline and 8 weeks ]
    Change from baseline to 8 weeks in blood vitamin D binding protein after vitamin D supplementation (comparison between pre- and post-supplementation cathelicidin levels using paired t-tests for repeated measures)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women age 18-65 who are current or former smokers
  • Serum calcium<10.5mg/dl
  • 25 OHD<20 ng/ml
  • CrCl ≥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, FEV1 greater than 50% predicted.
  • For smokers, current cigarette use (defined as regularly smoking 5 cigarettes per day)

Exclusion Criteria:

  • 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 >2L/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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02464059


Locations
United States, Maryland
Johns Hopkins Clinical Research Unit
Baltimore, Maryland, United States, 21224
United States, North Carolina
Meadowmont Pulmonary Research Clinic
Chapel Hill, North Carolina, United States, 27517
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Johns Hopkins University
Investigators
Principal Investigator: Michael B Drummond, MD University of North Carolina, Chapel Hill

Responsible Party: Michael (Brad) Drummond, MD, MHS, Associate Professor, Pulmonary and Critical Care Medicine, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02464059     History of Changes
Other Study ID Numbers: 16-2200
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be made publicly available

Keywords provided by Michael (Brad) Drummond, MD, MHS, University of North Carolina, Chapel Hill:
cathelicidin
vitamin D

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents