Assessment of Trace Elements, Systemic Inflammation and Electrolytes

Assessment of Trace Elements, Systemic Inflammation and Electrolytes in Patients With Chronic Obstructive Pulmonary Disease

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.

Study Overview

• Status: Completed
• Conditions: Copd
• Intervention / Treatment: Combination product: Laboratory Tests

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.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Minya, Egypt
    • Minia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: COPD patients; It is about 60 patients with Stable COPD	Combination product: Laboratory Tests; Measurement of serum level of CRP, tumor necrosis factor, zinc, copper, potassium, sodium, and magnesium in patients with stable COPD and during exacerbation.
ACTIVE_COMPARATOR: Acute exacerbation COPD; It is about 40 patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD).	Combination product: Laboratory Tests; Measurement of serum level of CRP, tumor necrosis factor, zinc, copper, potassium, sodium, and magnesium in patients with stable COPD and during exacerbation.
PLACEBO_COMPARATOR: healthy controls; It is about 40 healthy controls were included in the study	Combination product: Laboratory Tests; Measurement of serum level of CRP, tumor necrosis factor, zinc, copper, potassium, sodium, and magnesium in patients with stable COPD and during exacerbation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	from baseline to 72 hours
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	from baseline to 48 hours after the taking blood samle

Collaborators and Investigators

• Sponsor: Egymedicalpedia
• Investigators: Study Director: Mohammad O Abdel Aziz, Professor, Department of Internal medicine Minia university, Minia, Egypt

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2019
• Primary Completion (ACTUAL): December 1, 2019
• Study Completion (ACTUAL): December 15, 2019

Study Registration Dates

• First Submitted: January 4, 2023
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (ACTUAL): February 8, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: COPD; Biomarkers; Trace elements; Electrolytes
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: Rasha Abdelfattah

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No