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Assessment of Trace Elements, Systemic Inflammation and Electrolytes

Primary Purpose

Copd

Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Laboratory Tests
Sponsored by
Egymedicalpedia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Copd focused on measuring COPD, Biomarkers, Trace elements, Electrolytes

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: COPD patients Exclusion Criteria: Patients with Cardiovascular diseases, diabetes mellitus, chronic kidney disease, chronic liver disease, collagen vascular diseases, cancer, currently smoking, current pneumonia or inflammation, or refused to participate in the study

Sites / Locations

  • Minia university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

COPD patients

Acute exacerbation COPD

healthy controls

Arm Description

It is about 60 patients with Stable COPD

It is about 40 patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD).

It is about 40 healthy controls were included in the study

Outcomes

Primary Outcome Measures

Assessment of the pain resulted in COPD
The Pain was measured by using the visual analogue score (VAS) as Total scores vary from 0 to 10 in this method, with a higher score indicating more severe pain
Number of participants with abnormal laboratory test results
he study tried to assess some Laboratory Tests in blood and comparing the level of their results in patients with stable and patients with exacerbation of theirs disease and aslo comparing their values between patients who needed and those who did not need mechanical ventilation

Secondary Outcome Measures

Full Information

First Posted
January 4, 2023
Last Updated
February 6, 2023
Sponsor
Egymedicalpedia
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1. Study Identification

Unique Protocol Identification Number
NCT05718453
Brief Title
Assessment of Trace Elements, Systemic Inflammation and Electrolytes
Official Title
Assessment of Trace Elements, Systemic Inflammation and Electrolytes in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Egymedicalpedia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
COPD is one of the most common causes of health problems worldwide. It is a disease that is associated with several systemic features that affect its morbidity and mortality.
Detailed Description
The most prominent features of COPD are systemic inflammation and oxidative stress. There is growing interest in establishing the significance of systemic inflammatory biomarkers in COPD patients, as they could be useful in evaluating exacerbations, monitoring disease progression, and evaluating treatment outcomes. C-reactive protein (CRP) is a biomarker for systemic inflammation, produced mostly by hepatocytes in response to tissue injury or inflammation. Tumor necrosis factor - alpha (TNF-α) is a key modulator of the immune system's response to infection. At the sites of inflammation, this cytokine regulates the function of poly-morphs and lymphocytes, with essentially protective benefits for the host. Increased TNF-α production may enhance an injury process locally and also elevated circulating levels may have negative systemic consequences. Trace elements are hypothesized to play a role in the pathogenesis of many diseases, either directly or indirectly. Trace elements play an important function in the inhibition and activation of enzyme processes . Zinc, for example, is a co-factor for various enzymes and is important for cell membrane stability, protein synthesis, proper tissue growth, and nucleic acid metabolism. Severity of COPD exacerbation is associated with increased levels of copper (Cu) and zinc (Zn). Patients with COPD are liable for various electrolyte derangements, especially during exacerbations. Hyponatremia is typically observed in the final stages of COPD. Hypokalemia may also occur independently or concomitantly with hyponatremia, and because magnesium plays a role in muscle tone, a drop in magnesium levels in COPD is a component that reduces respiratory muscle function and causes muscle fatigue.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Copd
Keywords
COPD, Biomarkers, Trace elements, Electrolytes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Measurement of serum level of CRP, tumor necrosis factor, zinc, copper, potassium, sodium, and magnesium in patients with stable COPD and during exacerbation.
Masking
Participant
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COPD patients
Arm Type
Active Comparator
Arm Description
It is about 60 patients with Stable COPD
Arm Title
Acute exacerbation COPD
Arm Type
Active Comparator
Arm Description
It is about 40 patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD).
Arm Title
healthy controls
Arm Type
Placebo Comparator
Arm Description
It is about 40 healthy controls were included in the study
Intervention Type
Combination Product
Intervention Name(s)
Laboratory Tests
Intervention Description
Measurement of serum level of CRP, tumor necrosis factor, zinc, copper, potassium, sodium, and magnesium in patients with stable COPD and during exacerbation.
Primary Outcome Measure Information:
Title
Assessment of the pain resulted in COPD
Description
The Pain was measured by using the visual analogue score (VAS) as Total scores vary from 0 to 10 in this method, with a higher score indicating more severe pain
Time Frame
from baseline to 72 hours
Title
Number of participants with abnormal laboratory test results
Description
he study tried to assess some Laboratory Tests in blood and comparing the level of their results in patients with stable and patients with exacerbation of theirs disease and aslo comparing their values between patients who needed and those who did not need mechanical ventilation
Time Frame
from baseline to 48 hours after the taking blood samle

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: COPD patients Exclusion Criteria: Patients with Cardiovascular diseases, diabetes mellitus, chronic kidney disease, chronic liver disease, collagen vascular diseases, cancer, currently smoking, current pneumonia or inflammation, or refused to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad O Abdel Aziz, Professor
Organizational Affiliation
Department of Internal medicine Minia university, Minia, Egypt
Official's Role
Study Director
Facility Information:
Facility Name
Minia university
City
Minya
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Assessment of Trace Elements, Systemic Inflammation and Electrolytes

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