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

August 7, 2023 updated by: Ahmed Mohamed Ahmed, Sohag University
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) .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Settings: Dermatology outpatient clinics and Central Research Lab at Sohag University.

Study population: The study will include adult patients complaining of CSU and a group of age and sex-matched healthy controls (blood donors).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum level of adenosine deaminase
Time Frame: 3 months
Difference in serum level of adenosine deaminase between CSU group and control group
3 months
Serum level of IgE
Time Frame: 3 months
Difference in serum level of IgE between CSU group and control group
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Study Director: Ramadan Saleh, MD, Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 15, 2023

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

March 31, 2024

Study Registration Dates

First Submitted

August 7, 2023

First Submitted That Met QC Criteria

August 7, 2023

First Posted (Actual)

August 15, 2023

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 7, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-23-07-12MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be shared upon request to the study director

IPD Sharing Time Frame

Data will become available after study due for unlimited period of time.

IPD Sharing Access Criteria

IPD will be shared upon request by the study director. Patients' names will be anonymous.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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