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Association of Cathelicidin and Vitamin D Levels With the Category and Course of COPD (COPD)

Primary Purpose

Chronic Obstructive Pulmonary Disease, Chronic Obstructive Pulmonary Disease Moderate, Chronic Obstructive Pulmonary Disease Severe

Status
Completed
Phase
Phase 4
Locations
Kazakhstan
Study Type
Interventional
Intervention
Cholecalciferol Liquid
Sponsored by
Karaganda Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, vitamin D, cathelicidin, antimicrobial peptide

Eligibility Criteria

18 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Clinically confirmed chronic obstructive pulmonary disease

Exclusion Criteria:

  • age under 18
  • pregnancy
  • mental disorders
  • cancer
  • terminal renal and hepatic insufficiency

Sites / Locations

  • Karaganda Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Active Comparator

Active Comparator

Arm Label

normal vitamin D levels

Mild vitamin D deficiency

Moderate vitamin D deficiency

Severe vitamin D deficiency

Arm Description

Patients with normal vitamin D levels (30-100ng/ml) No interference is implied. Observation only

Patients with mild vitamin D deficiency (20-29 ng/ml)They will receive 4000 IU of cholecalciferol per day for 3 months

Patients with moderate vitamin D deficiency (10-19 ng/ml) will receive cholecalciferol at a dose of 5000-6000 IU daily for 3 months

Patients with moderate vitamin D deficiency (10-19 ng/ml) will receive cholecalciferol at a dose of 7000-8000 IU daily for 3 months

Outcomes

Primary Outcome Measures

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
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
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
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
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
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

Secondary Outcome Measures

Full Information

First Posted
May 25, 2022
Last Updated
June 21, 2022
Sponsor
Karaganda Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05431218
Brief Title
Association of Cathelicidin and Vitamin D Levels With the Category and Course of COPD
Acronym
COPD
Official Title
Association of Cathelicidin and Vitamin D Levels With the Category and Course of COPD
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
February 18, 2020 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Karaganda Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Chronic Obstructive Pulmonary Disease Moderate, Chronic Obstructive Pulmonary Disease Severe
Keywords
COPD, vitamin D, cathelicidin, antimicrobial peptide

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
normal vitamin D levels
Arm Type
No Intervention
Arm Description
Patients with normal vitamin D levels (30-100ng/ml) No interference is implied. Observation only
Arm Title
Mild vitamin D deficiency
Arm Type
Active Comparator
Arm Description
Patients with mild vitamin D deficiency (20-29 ng/ml)They will receive 4000 IU of cholecalciferol per day for 3 months
Arm Title
Moderate vitamin D deficiency
Arm Type
Active Comparator
Arm Description
Patients with moderate vitamin D deficiency (10-19 ng/ml) will receive cholecalciferol at a dose of 5000-6000 IU daily for 3 months
Arm Title
Severe vitamin D deficiency
Arm Type
Active Comparator
Arm Description
Patients with moderate vitamin D deficiency (10-19 ng/ml) will receive cholecalciferol at a dose of 7000-8000 IU daily for 3 months
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol Liquid
Intervention Description
daily single dose of the drug in the first half of the day in an individually selected dose for 3 months
Primary Outcome Measure Information:
Title
Dynamics of vitamin D levels at baseline and 3 months
Description
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
Time Frame
At baseline and 3 months
Title
Dynamics of vitamin D levels at baseline and 6 months
Description
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
Time Frame
At baseline and 6 months
Title
Dynamics of vitamin D levels at 3 months and 6 months
Description
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
Time Frame
At 3 months and 6 months
Title
Dynamics of cathelicidin levels at baseline and 3 months
Description
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
Time Frame
At baseline and 3 months
Title
Dynamics of cathelicidin levels at baseline and 6 months
Description
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
Time Frame
At baseline and 6 months
Title
Dynamics of cathelicidin levels at 3 months and 6 months
Description
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
Time Frame
At 3 months and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Clinically confirmed chronic obstructive pulmonary disease Exclusion Criteria: age under 18 pregnancy mental disorders cancer terminal renal and hepatic insufficiency
Facility Information:
Facility Name
Karaganda Medical University
City
Karaganda
ZIP/Postal Code
100000
Country
Kazakhstan

12. IPD Sharing Statement

Links:
URL
https://pubmed.ncbi.nlm.nih.gov/30774329/
Description
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 321-330
URL
http://www.who.int
Description
World Health Organization official website
URL
http://www.kaznu.kz/ru/20215/news/one/16350/
Description
International conference "Respiratory Junction Almaty: Where East meets West". 02.04.2019
URL
http://www.ncbi.nlm.nih.gov/pubmed/25973241
Description
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):740-745
URL
http://www.ncbi.nlm.nih.gov/pubmed/30245735
Description
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 Scholar
URL
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3904447/
Description
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.2013.01.001
URL
http://www.ncbi.nlm.nih.gov/pubmed/30811465
Description
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.0212628
URL
http://www.rosmedlib.ru/book/ISBN9785970440582.html
Description
Gromova O.A., Vitamin D - paradigm shift [Electronic resource] / Gromova O.A., Torshin I.Yu. - M. : GEOTAR-Media, 2017. - 576 p. - ISBN 978-5-9704-4058-2
URL
https://pubmed.ncbi.nlm.nih.gov/21378345/
Description
Vitamin D Supplement Doses and Serum 25-Hydroxyvitamin D in the Range Associated with Cancer Prevention C.F. GARLAND, C.B. FRENCH, L.L. BAGGERLY and R.P. HEANEY Anticancer Research February 2011 vol.31 no.2 6007-611

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Association of Cathelicidin and Vitamin D Levels With the Category and Course of COPD

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