Association of Cathelicidin and Vitamin D Levels With the Category and Course of COPD
Condition: Chronic Obstructive Pulmonary Disease; Chronic Obstructive Pulmonary Disease Moderate; Chronic Obstructive Pulmonary Disease Severe
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Cholecalciferol Liquid
Intervention type(s): Drug
Intervention description(s): daily single dose of the drug in the first half of the day in an individually selected dose for 3 months
Intervention MeSH terms: Cholecalciferol; Vitamin D
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 severe
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: COPD; vitamin D; cathelicidin; antimicrobial peptide