Assessment of Serum Levels of Adenosine Deaminase and Immunoglobulin E in Patients With Chronic Spontaneous Urticaria

Sponsor

Sohag University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05992987

Collaborator

(none)

Enrollment

7.5

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

adenosine deaminase activity (ADA) has been reported to be elevated in various diseases such as psoriasis, acne and juvenile idiopathic arthritis. There is no previous studies that assessed ADA in chronic spontaneous urticaria (CSU) .

Condition or Disease	Intervention/Treatment	Phase
Chronic Spontaneous Urticaria	Diagnostic Test: Adenosine deaminase serum level Diagnostic Test: IgE antibodies serum level

Study Design

Study Type:

Observational

Anticipated Enrollment :

90 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Assessment of Serum Levels of Adenosine Deaminase and Immunoglobulin E in Patients With Chronic Spontaneous Urticaria

Anticipated Study Start Date :

Aug 15, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Mar 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
CSU group Adult patients complaining of chronic spontaneous urticaria (CSU)	Diagnostic Test: Adenosine deaminase serum level Adenosine deaminase will be measured by enzymatic (clorometric / kinetic) method (Diazyme laboratories, San Diego, California, USA). Diagnostic Test: IgE antibodies serum level Level of IgE will be measured by electrochemiluminesence immunoassay (ECLIA, automatic cobase immunoassay, Roche Diagnostics GmbH, Mannheim, USA).
Control group A group of age and sex-matched healthy controls (blood donors).	Diagnostic Test: Adenosine deaminase serum level Adenosine deaminase will be measured by enzymatic (clorometric / kinetic) method (Diazyme laboratories, San Diego, California, USA). Diagnostic Test: IgE antibodies serum level Level of IgE will be measured by electrochemiluminesence immunoassay (ECLIA, automatic cobase immunoassay, Roche Diagnostics GmbH, Mannheim, USA).

Arm

Intervention/Treatment

CSU group

Adult patients complaining of chronic spontaneous urticaria (CSU)

Diagnostic Test: Adenosine deaminase serum level

Adenosine deaminase will be measured by enzymatic (clorometric / kinetic) method (Diazyme laboratories, San Diego, California, USA).

Diagnostic Test: IgE antibodies serum level

Level of IgE will be measured by electrochemiluminesence immunoassay (ECLIA, automatic cobase immunoassay, Roche Diagnostics GmbH, Mannheim, USA).

Control group

A group of age and sex-matched healthy controls (blood donors).

Diagnostic Test: Adenosine deaminase serum level

Adenosine deaminase will be measured by enzymatic (clorometric / kinetic) method (Diazyme laboratories, San Diego, California, USA).

Diagnostic Test: IgE antibodies serum level

Level of IgE will be measured by electrochemiluminesence immunoassay (ECLIA, automatic cobase immunoassay, Roche Diagnostics GmbH, Mannheim, USA).

Outcome Measures

Primary Outcome Measures

Serum level of adenosine deaminase [3 months]
Difference in serum level of adenosine deaminase between CSU group and control group
Serum level of IgE [3 months]
Difference in serum level of IgE between CSU group and control group

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

adult patients complaining of CSU and a group of age and sex-matched healthy controls (blood donors).

Exclusion Criteria:

Pregnancy and lactation.
Patients with systemic diseases, especially those with autoimmune diseases and infections.
Patients with skin diseases.
Patients on medications such as antibiotics, nonsteroidal anti-inflammatory drugs, angiotensin-converting enzyme inhibitors, anticonvulsants, penicillin, and combined oral contraceptives.