Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05431218 |
| Other study ID # |
VitD COPD |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
February 18, 2020 |
| Est. completion date |
December 31, 2021 |
Study information
| Verified date |
April 2024 |
| Source |
Karaganda Medical University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
