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

NCT05431218 | Completed Phase 4

• 1 other identifier: VitD COPD
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; Chronic Obstructive Pulmonary Disease Moderate; Chronic Obstructive Pulmonary Disease Severe

Keywords

COPD; vitamin D; cathelicidin; antimicrobial peptide

Outcome Measures

Primary Outcomes (6)

• 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

  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

  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

  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

  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

  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

  At 3 months and 6 months

Study Arms (4)

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

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

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

Drug: Cholecalciferol Liquid

Interventions

Cholecalciferol Liquid DRUG

daily single dose of the drug in the first half of the day in an individually selected dose for 3 months

Also known as: D vitamin

Mild vitamin D deficiency; Moderate vitamin D deficiency; Severe vitamin D deficiency

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Clinically confirmed chronic obstructive pulmonary disease

You may not qualify if:

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

Sponsors & Collaborators

• Karaganda Medical University: lead

Study Sites (1)

Karaganda Medical University

Karaganda, 100000, Kazakhstan

Location

Related Links

• 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
• World Health Organization official website
• International conference "Respiratory Junction Almaty: Where East meets West". 02.04.2019
• 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
• 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
• 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
• 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
• 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

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: June 24, 2022
• Study Start: February 18, 2020
• Primary Completion: December 30, 2021
• Study Completion: December 31, 2021
• Last Updated: April 12, 2024

Record last verified: 2024-04

Locations

KA (1)