Pulmonary Disease, Chronic ObstructivePhase 2NCT02464059
Cathelicidin and Vitamin D: Impact on Populations At-Risk and With COPD
A Phase 2 study testing Vitamin D3 in people with Pulmonary Disease, Chronic Obstructive, run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Nov 2015to 15 Apr 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Clinical Research Unit
Baltimore, Maryland, 21224
Meadowmont Pulmonary Research Clinic
Chapel Hill, North Carolina, 27517
About this study
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.
Read the 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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Vitamin D3
- Keywords
- Cathelicidin, Vitamin D
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
Also called cholecalciferol
Oral supplementation with 50,000 IU vitamin D3 weekly for eight weeks in individuals with reduced vitamin D levels.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 | Experimental | Oral supplementation with 50,000 IU vitamin D3 weekly for eight weeks Receives: Drug: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline and 8 weeks
Secondary outcomes (2)
Change From Baseline in Blood Cathelicidin at 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)
Measured: Baseline and 8 weeks
Change From Baseline in Blood Vitamin D Binding Protein at 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)
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study start10 Nov 2015
- Primary completion15 Apr 2020
- Study completion15 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Michael B Drummond, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464059
- Sponsor's protocol ID
- 16-2200
- Status last verified
- Apr 2020
- First submitted
- 3 Jun 2015
- Last updated
- 24 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cathelicidin and Vitamin D: Impact on Populations At-Risk and With COPD
- ClinicalTrials.gov ID
- NCT02464059
- Acronym / sponsor ID
- 16-2200
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Cathelicidin, Vitamin D
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Johns Hopkins University
- Study start
- 10 Nov 2015 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 8 Jun 2015 (estimated)
- Results
- Posted 24 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 | Experimental | Drug: Vitamin D3Oral supplementation with 50,000 IU vitamin D3 weekly for eight weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3Also: cholecalciferolOral supplementation with 50,000 IU vitamin D3 weekly for eight weeks in individuals with reduced vitamin D levels. | Drug | Vitamin D3 |
Primary outcome
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)
2 secondary outcomes
Change From Baseline in Blood Cathelicidin at 8 Weeks
Time frame: Baseline and 8 weeks
Change From Baseline in Blood Vitamin D Binding Protein at 8 Weeks
Time frame: Baseline and 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael B Drummond, MD principal investigator
University of North Carolina, Chapel Hill
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin D3 in people with Pulmonary Disease, Chronic Obstructive, run by University of North Carolina, Chapel Hill at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Lung Cathelicidin Level at 8 Weeks (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2020.