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

Sponsor

Karaganda Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT05431218

Collaborator

(none)

120

Enrollment

Location

Arms

22.4

Actual Duration (Months)

5.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease Chronic Obstructive Pulmonary Disease Moderate Chronic Obstructive Pulmonary Disease Severe	Drug: Cholecalciferol Liquid	Phase 4

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

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention 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 severeThe 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)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Feb 18, 2020

Actual Primary Completion Date :

Dec 30, 2021

Actual Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: normal vitamin D levels Patients with normal vitamin D levels (30-100ng/ml) No interference is implied. Observation only
Active Comparator: Mild vitamin D deficiency Patients with mild vitamin D deficiency (20-29 ng/ml)They will receive 4000 IU of cholecalciferol per day for 3 months	Drug: Cholecalciferol Liquid daily single dose of the drug in the first half of the day in an individually selected dose for 3 months
Active Comparator: Moderate vitamin D deficiency Patients with moderate vitamin D deficiency (10-19 ng/ml) will receive cholecalciferol at a dose of 5000-6000 IU daily for 3 months	Drug: Cholecalciferol Liquid daily single dose of the drug in the first half of the day in an individually selected dose for 3 months
Active Comparator: Severe vitamin D deficiency Patients with moderate vitamin D deficiency (10-19 ng/ml) will receive cholecalciferol at a dose of 7000-8000 IU daily for 3 months	Drug: Cholecalciferol Liquid daily single dose of the drug in the first half of the day in an individually selected dose for 3 months

Outcome Measures

Primary Outcome Measures

Dynamics of vitamin D levels at baseline and 3 months [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 [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 [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 [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 [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 [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