Assessment of Trace Elements, Systemic Inflammation and Electrolytes

Egymedicalpedia

Status and phase: Completed; Phase 1

Conditions: Copd

Treatments: Combination Product: Laboratory Tests

Study type: Interventional

Funder types: Industry

Identifiers

NCT05718453

Rasha Abdelfattah

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 40 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 3 patient groups, including a placebo group

COPD patients

Active Comparator group

Description:

It is about 60 patients with Stable COPD

Treatment:

Combination Product: Laboratory Tests

Acute exacerbation COPD

Active Comparator group

Description:

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

Treatment:

Combination Product: Laboratory Tests

healthy controls

Placebo Comparator group

Description:

It is about 40 healthy controls were included in the study

Treatment:

Combination Product: Laboratory Tests