- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02464059
Cathelicidin and Vitamin D: Impact on Populations At-Risk and With COPD
July 22, 2020 updated by: University of North Carolina, Chapel Hill
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
23
Phase
- Phase 2
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
-
-
Maryland
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Baltimore, Maryland, United States, 21224
- Johns Hopkins Clinical Research Unit
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North Carolina
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Chapel Hill, North Carolina, United States, 27517
- Meadowmont Pulmonary Research Clinic
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-
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
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Men and women age 18-65 who are current or former smokers
- Serum calcium<10.5mg/dL
- 25-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)
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 >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.
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
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vitamin D3
Oral supplementation with 50,000 IU vitamin D3 weekly for eight weeks
|
Oral supplementation with 50,000 IU vitamin D3 weekly for eight weeks in individuals with reduced vitamin D levels.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Baseline and 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Baseline and 8 weeks
|
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)
|
Baseline and 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Michael B Drummond, MD, University of North Carolina, Chapel Hill
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)
November 10, 2015
Primary Completion (Actual)
April 15, 2020
Study Completion (Actual)
April 15, 2020
Study Registration Dates
First Submitted
June 3, 2015
First Submitted That Met QC Criteria
June 4, 2015
First Posted (Estimate)
June 8, 2015
Study Record Updates
Last Update Posted (Actual)
July 24, 2020
Last Update Submitted That Met QC Criteria
July 22, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-2200
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Individual participant data will not be made publicly available
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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