Chronic Obstructive Pulmonary DiseasePhase 4COPDNCT05431218
Association of Cathelicidin and Vitamin D Levels With the Category and Course of COPD
A Phase 4 study testing Cholecalciferol Liquid in people with Chronic Obstructive Pulmonary Disease and Chronic Obstructive Pulmonary Disease Moderate, run by Karaganda Medical University at 1 site in Kazakhstan.
Trial summary
Recruitment of patients with COPD. Assessment of clinical status, determination of vitamin D and cathelicidin levels. In the group with vitamin D deficiency, patients receive cholecalciferol (vitamin D) daily for 3 months. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Chronic Obstructive Pulmonary Disease Moderate, Chronic Obstructive Pulmonary Disease Severe
- What is being tested?
- Cholecalciferol Liquid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteKazakhstan
- Study dates
- 18 Feb 2020to 31 Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically confirmed chronic obstructive pulmonary disease
Who cannot join
- age under 18
- pregnancy
- mental disorders
- cancer
- terminal renal and hepatic insufficiency
Trial locations and contacts
1 site in 1 country.
About this study
Recruitment of patients with COPD. Assessment of clinical status, determination of vitamin D and cathelicidin levels. In the group with vitamin D deficiency, patients receive cholecalciferol (vitamin D) daily for 3 months. After 3 months, the clinical status was assessed again, the level of vitamin D and cathelicidin was determined. When vitamin D levels normalize, cholecalciferol replacement therapy is discontinued for 3 months. After that, a control inspection and laboratory tests are performed.
Read the detailed description
Interventional prospective research design.
The study will be conducted on patients with moderate and severe COPD. The material for the study will be the blood and sputum of patients with COPD.
Research methods: biochemical, enzyme immunoassay, bacteriological, radiological, spirography, clinical, statistical analysis.
The recruitment of patients is carried out in the pulmonology department of the hospital according to the inclusion and exclusion criteria. Patient participation is voluntary. First, the patient is told about the study. If he agrees, he signs an informed consent to conduct research.
Clinical examination of the patient, anthropometry, standard COPD assessment tests will be conducted in the hospital.
Laboratory tests will be conducted in medical institutions in Karaganda and will include a detailed general blood test, determination of fibrinogen and CRP (C-reactive protein) levels, general sputum analysis and bacteriological sputum examination.
Instrumental studies are carried out in medical institutions of the city: spirometry (determination of FEV1 (forced exhalation volume), Gensler index and Tiffno), lung radiography.
The study of vitamin D and cathelicidin is carried out by the ELISA method in the laboratory of the Medical University. Assessment of vitamin D status will be carried out by determining the level of total 25(OH)D (circulating serum, total D2 and D3) with verification of the method relative to international standards (National Institute of Standards and Technology - National Institute of Standards and Technology (NIST), Vitamin D External Quality Assessment Scheme (DEQAS)). The interpretation of vitamin D levels will be carried out according to international standards:
less than 10 ng/ml severe deficiency; 10-20 ng/ml moderate deficiency; 20-30 ng/ml mild deficiency; 30-100 ng/ml Norm; more than 100 ng/ml toxic level.
Quantitative determination of the level of antimicrobial peptide cathelicidin (LL-37) in blood serum will be carried out using enzyme immunoassay (NK321, HumanLL-37 ELISA Kit, Hycult biotech, the Netherlands) in accordance with the manufacturer's instructions. . Normal levels of LL-37: 50-80 ng/ml.
Among the patients with COPD selected at the outpatient stage, persons with vitamin 25(OH) deficiency were identifiedD in the blood (insufficiency/deficiency). In this group, patients received a therapeutic dose of an aqueous solution of cholecalciferol for three months. The therapeutic dose of an aqueous solution of cholecalciferol will be calculated individually according to clinical recommendations for the treatment of vitamin D deficiency and insufficiency.
Patients will continue treatment of the underlying COPD disease according to the clinical protocol. Vitamin therapy is an addition to the main treatment, it should strengthen the immunity and protective abilities of the body. After three months of replacement therapy with cholecalciferol and the next 3 months without it, clinical, laboratory and instrumental research methods will be repeated to assess the effectiveness.
Statistical processing of the research results is supposed to be carried out using statistical packages Excel 2010 (Microsoft, USA), Statistica 10.0 (StatSoft, Inc., USA). Methods of parametric and nonparametric statistics will be used: Student's criterion (t), Mann-Whitney (U), Wilcoxon; correlation analysis with calculation of Spearman's correlation coefficient (R). To compare the case-control groups with a quantitative assessment of the relationship between the factor and the outcome, the odds ratio (OR) with 95% CI will be calculated.
- Conditions
- Chronic Obstructive Pulmonary Disease, Chronic Obstructive Pulmonary Disease Moderate, Chronic Obstructive Pulmonary Disease Severe
- Being tested
- Cholecalciferol Liquid
- Keywords
- COPD, vitamin D, cathelicidin, antimicrobial peptide
- 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.
Cholecalciferol LiquidDrug
Also called D vitamin
daily single dose of the drug in the first half of the day in an individually selected dose for 3 months
| Study group | Role | What they receive |
|---|---|---|
| normal vitamin D levels | No intervention | Patients with normal vitamin D levels (30-100ng/ml) No interference is implied. Observation only |
| Mild vitamin D deficiency | Active comparator | Patients with mild vitamin D deficiency (20-29 ng/ml)They will receive 4000 IU of cholecalciferol per day for 3 months Receives: Drug: Cholecalciferol Liquid |
| Moderate vitamin D deficiency | Active comparator | Patients with moderate vitamin D deficiency (10-19 ng/ml) will receive cholecalciferol at a dose of 5000-6000 IU daily for 3 months Receives: Drug: Cholecalciferol Liquid |
| Severe vitamin D deficiency | Active comparator | Patients with moderate vitamin D deficiency (10-19 ng/ml) will receive cholecalciferol at a dose of 7000-8000 IU daily for 3 months Receives: Drug: Cholecalciferol Liquid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamics of vitamin D levels at baseline and 3 months
Assessment of the levels of vitamin D (ng / ml) in blood plasma and evaluate the dynamics of the measurement of the indicator in the same patient in different periods of time, and compare the indicators in groups of patients
Measured: At baseline and 3 months
Dynamics of vitamin D levels at baseline and 6 months
Assessment of the levels of vitamin D (ng / ml) in blood plasma and evaluate the dynamics of the measurement of the indicator in the same patient in different periods of time, and compare the indicators in groups of patients
Measured: At baseline and 6 months
Dynamics of vitamin D levels at 3 months and 6 months
Assessment of the levels of vitamin D (ng / ml) in blood plasma and evaluate the dynamics of the measurement of the indicator in the same patient in different periods of time, and compare the indicators in groups of patients
Measured: At 3 months and 6 months
Dynamics of cathelicidin levels at baseline and 3 months
Assessment of cathelicidin levels (ng / ml) in blood plasma and and evaluate the dynamics of the measurement of the indicator in the same patient in different periods of time, and compare the indicators in groups of patients
Measured: At baseline and 3 months
Dynamics of cathelicidin levels at baseline and 6 months
Assessment of cathelicidin levels (ng / ml) in blood plasma and and evaluate the dynamics of the measurement of the indicator in the same patient in different periods of time, and compare the indicators in groups of patients
Measured: At baseline and 6 months
Dynamics of cathelicidin levels at 3 months and 6 months
Assessment of cathelicidin levels (ng / ml) in blood plasma and evaluate the dynamics of the measurement of the indicator in the same patient in different periods of time, and compare the indicators in groups of patients
Measured: At 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start18 Feb 2020
- Primary completion30 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study suggests dividing patients, depending on the initial vitamin D level, into 4 groups: normal level, deficiency, deficiency and severe deficiency. Also, the division into groups according to the severity of chronic obstructive pulmonary disease: mild, moderate, severe and extremely severe
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karaganda Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431218
- Sponsor's protocol ID
- VitD COPD
- Acronym
- COPD
- Status last verified
- Apr 2024
- First submitted
- 25 May 2022
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Cathelicidin and Vitamin D Levels With the Category and Course of COPD
- ClinicalTrials.gov ID
- NCT05431218
- Acronym / sponsor ID
- COPD / VitD COPD
- Conditions
- Chronic Obstructive Pulmonary Disease, Chronic Obstructive Pulmonary Disease Moderate, Chronic Obstructive Pulmonary Disease Severe
- Keywords
- COPD, vitamin D, cathelicidin, antimicrobial peptide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Karaganda Medical UniversityUniversity, hospital or other
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 24 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recruitment of patients with COPD. Assessment of clinical status, determination of vitamin D and cathelicidin levels. In the group with vitamin D deficiency, patients receive cholecalciferol (vitamin D) daily for 3 months. After 3 months, the clinical status was assessed again, the level of vitamin D and cathelicidin was determined. When vitamin D levels normalize, cholecalciferol replacement therapy is discontinued for 3 months. After that, a control inspection and laboratory tests are performed.
Detailed description
Interventional prospective research design.
The study will be conducted on patients with moderate and severe COPD. The material for the study will be the blood and sputum of patients with COPD.
Research methods: biochemical, enzyme immunoassay, bacteriological, radiological, spirography, clinical, statistical analysis.
The recruitment of patients is carried out in the pulmonology department of the hospital according to the inclusion and exclusion criteria. Patient participation is voluntary. First, the patient is told about the study. If he agrees, he signs an informed consent to conduct research.
Clinical examination of the patient, anthropometry, standard COPD assessment tests will be conducted in the hospital.
Laboratory tests will be conducted in medical institutions in Karaganda and will include a detailed general blood test, determination of fibrinogen and CRP (C-reactive protein) levels, general sputum analysis and bacteriological sputum examination.
Instrumental studies are carried out in medical institutions of the city: spirometry (determination of FEV1 (forced exhalation volume), Gensler index and Tiffno), lung radiography.
The study of vitamin D and cathelicidin is carried out by the ELISA method in the laboratory of the Medical University. Assessment of vitamin D status will be carried out by determining the level of total 25(OH)D (circulating serum, total D2 and D3) with verification of the method relative to international standards (National Institute of Standards and Technology - National Institute of Standards and Technology (NIST), Vitamin D External Quality Assessment Scheme (DEQAS)). The interpretation of vitamin D levels will be carried out according to international standards:
less than 10 ng/ml severe deficiency; 10-20 ng/ml moderate deficiency; 20-30 ng/ml mild deficiency; 30-100 ng/ml Norm; more than 100 ng/ml toxic level.
Quantitative determination of the level of antimicrobial peptide cathelicidin (LL-37) in blood serum will be carried out using enzyme immunoassay (NK321, HumanLL-37 ELISA Kit, Hycult biotech, the Netherlands) in accordance with the manufacturer's instructions. . Normal levels of LL-37: 50-80 ng/ml.
Among the patients with COPD selected at the outpatient stage, persons with vitamin 25(OH) deficiency were identifiedD in the blood (insufficiency/deficiency). In this group, patients received a therapeutic dose of an aqueous solution of cholecalciferol for three months. The therapeutic dose of an aqueous solution of cholecalciferol will be calculated individually according to clinical recommendations for the treatment of vitamin D deficiency and insufficiency.
Patients will continue treatment of the underlying COPD disease according to the clinical protocol. Vitamin therapy is an addition to the main treatment, it should strengthen the immunity and protective abilities of the body. After three months of replacement therapy with cholecalciferol and the next 3 months without it, clinical, laboratory and instrumental research methods will be repeated to assess the effectiveness.
Statistical processing of the research results is supposed to be carried out using statistical packages Excel 2010 (Microsoft, USA), Statistica 10.0 (StatSoft, Inc., USA). Methods of parametric and nonparametric statistics will be used: Student's criterion (t), Mann-Whitney (U), Wilcoxon; correlation analysis with calculation of Spearman's correlation coefficient (R). To compare the case-control groups with a quantitative assessment of the relationship between the factor and the outcome, the odds ratio (OR) with 95% CI will be calculated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The study suggests dividing patients, depending on the initial vitamin D level, into 4 groups: normal level, deficiency, deficiency and severe deficiency. Also, the division into groups according to the severity of chronic obstructive pulmonary disease: mild, moderate, severe and extremely severe
| Arm | Type | Receives |
|---|---|---|
| normal vitamin D levels | No intervention | –Patients with normal vitamin D levels (30-100ng/ml) No interference is implied. Observation only |
| Mild vitamin D deficiency | Active comparator | Drug: Cholecalciferol LiquidPatients with mild vitamin D deficiency (20-29 ng/ml)They will receive 4000 IU of cholecalciferol per day for 3 months |
| Moderate vitamin D deficiency | Active comparator | Drug: Cholecalciferol LiquidPatients with moderate vitamin D deficiency (10-19 ng/ml) will receive cholecalciferol at a dose of 5000-6000 IU daily for 3 months |
| Severe vitamin D deficiency | Active comparator | Drug: Cholecalciferol LiquidPatients with moderate vitamin D deficiency (10-19 ng/ml) will receive cholecalciferol at a dose of 7000-8000 IU daily for 3 months |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinically confirmed chronic obstructive pulmonary disease
Key exclusion criteria (5 listed)
- age under 18
- pregnancy
- mental disorders
- cancer
- terminal renal and hepatic insufficiency
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 |
|---|---|---|
| Cholecalciferol LiquidAlso: D vitamindaily single dose of the drug in the first half of the day in an individually selected dose for 3 months | Drug | Mild vitamin D deficiency, Moderate vitamin D deficiency, Severe vitamin D deficiency |
Primary outcome
Dynamics of vitamin D levels at baseline and 3 months
Time frame: At baseline and 3 months
Assessment of the levels of vitamin D (ng / ml) in blood plasma and evaluate the dynamics of the measurement of the indicator in the same patient in different periods of time, and compare the indicators in groups of patients
Dynamics of vitamin D levels at baseline and 6 months
Time frame: At baseline and 6 months
Assessment of the levels of vitamin D (ng / ml) in blood plasma and evaluate the dynamics of the measurement of the indicator in the same patient in different periods of time, and compare the indicators in groups of patients
Dynamics of vitamin D levels at 3 months and 6 months
Time frame: At 3 months and 6 months
Assessment of the levels of vitamin D (ng / ml) in blood plasma and evaluate the dynamics of the measurement of the indicator in the same patient in different periods of time, and compare the indicators in groups of patients
Dynamics of cathelicidin levels at baseline and 3 months
Time frame: At baseline and 3 months
Assessment of cathelicidin levels (ng / ml) in blood plasma and and evaluate the dynamics of the measurement of the indicator in the same patient in different periods of time, and compare the indicators in groups of patients
Dynamics of cathelicidin levels at baseline and 6 months
Time frame: At baseline and 6 months
Assessment of cathelicidin levels (ng / ml) in blood plasma and and evaluate the dynamics of the measurement of the indicator in the same patient in different periods of time, and compare the indicators in groups of patients
Dynamics of cathelicidin levels at 3 months and 6 months
Time frame: At 3 months and 6 months
Assessment of cathelicidin levels (ng / ml) in blood plasma and evaluate the dynamics of the measurement of the indicator in the same patient in different periods of time, and compare the indicators in groups of patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Uysal P, Simsek G, Durmus S, Sozer V. Evaluation of plasma antimicrobial peptide LL-37 and nuclear factor-kappaB levels in stable chronic obstructive pulmonary disease 25 January 2019 Volume 2019:14 Pages 321-330Link provided by the sponsor.
- World Health Organization official websiteLink provided by the sponsor.
- Yang YM, Guo YF, Zhang HS, Sun TY. Antimicrobial peptide LL-37 circulating levels in chronic obstructive pulmonary disease patients with high risk of frequent exacerbations. J Thorac Dis. 2015;7(4):740-745Link provided by the sponsor.
- V. Casanova, F.H. Sousa, C. Stevens, P. Barlow Antiviral therapeutic approaches for human rhinovirus infections Future Virol., 13 (2018), pp. 505-518 CrossRefView Record in ScopusGoogle ScholarLink provided by the sponsor.
- Roby KD, Nardo AD. Innate immunity and the role of the antimicrobial peptide cathelicidin in inflammatory skin disease. Drug Discov Today Dis Mech. 2013;10(3-4):e79-e82. doi:10.1016/j.ddmec.2013.01.001Link provided by the sponsor.
- Burkes RM, Astemborski J, Lambert AA, et al. Plasma cathelicidin and longitudinal lung function in current and former smokers. PLoS One. 2019;14(2):e0212628. Published 2019 Feb 27. doi:10.1371/journal.pone.0212628Link provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cholecalciferol Liquid in people with Chronic Obstructive Pulmonary Disease and Chronic Obstructive Pulmonary Disease Moderate, run by Karaganda Medical University at 1 site in Kazakhstan.
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 1 inclusion and 5 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 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dynamics of vitamin D levels at baseline and 3 months (time frame: At baseline and 3 months). The study lists 6 primary outcomes in all. 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 12 Apr 2024.