Assessment of Trace Elements, Systemic Inflammation and Electrolytes

NCT ID: NCT05718453

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2019-12-15

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.

Conditions

Copd

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

COPD patients

It is about 60 patients with Stable COPD

Group Type: ACTIVE_COMPARATOR

Laboratory Tests

Intervention Type: COMBINATION_PRODUCT

Measurement of serum level of CRP, tumor necrosis factor, zinc, copper, potassium, sodium, and magnesium in patients with stable COPD and during exacerbation.

Acute exacerbation COPD

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

Group Type: ACTIVE_COMPARATOR

Laboratory Tests

Intervention Type: COMBINATION_PRODUCT

Measurement of serum level of CRP, tumor necrosis factor, zinc, copper, potassium, sodium, and magnesium in patients with stable COPD and during exacerbation.

healthy controls

It is about 40 healthy controls were included in the study

Group Type: PLACEBO_COMPARATOR

Laboratory Tests

Intervention Type: COMBINATION_PRODUCT

Measurement of serum level of CRP, tumor necrosis factor, zinc, copper, potassium, sodium, and magnesium in patients with stable COPD and during exacerbation.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Egymedicalpedia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohammad O Abdel Aziz, Professor

Role: STUDY_DIRECTOR

Department of Internal medicine Minia university, Minia, Egypt

Locations

Minia university

Minya, , Egypt

Countries

Egypt

Other Identifiers

Rasha Abdelfattah

Identifier Type: -

Identifier Source: org_study_id