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

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