Evaluation of Toxic Metals, Trace Elements and Total Antioxidant Activity in Children With Recurrent Wheezing

NCT ID: NCT00749528

Last Updated: 2012-03-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 95 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2008-07-31

Brief Summary

The purpose of this study is to evaluate hair trace elements and toxic metals and plasma total antioxidant activity in children with recurrent wheezing and to evaluate whether these toxic metals and trace elements have any impact on serum cytokine levels.

Detailed Description

Context:

In many studies it was demonstrated that children are much more susceptible than adults for environmental toxic metal exposure. Hair analysis is a promising tool for routine clinical screening and diagnosis of heavy metal exposure and essential trace element states in the human body. Additionally it was demonstrated that oxidants and antioxidants play a central role in the pathogenesis of many pulmonary diseases including asthma. Furthermore, toxic metals, trace elements and oxidative stress have many pivotal role on immune system.

Objective:

To evaluate and compare hair toxic metals, hair essential trace elements levels and plasma total antioxidant activity between children with recurrent wheezing and age and sex matched healthy children.

Intervention: Hair samples will be collected for the analysis of the toxic metals, trace elements. Blood samples will be collected for the analysis of the cytokine levels and plasma antioxidant activity.

Study Measures:

Differences in hair toxic metals, hair trace elements, plasma cytokine levels and plasma total antioxidant activity will be compared between children with recurrent wheezing and age-sex matched healthy children

Conditions

Asthma; Wheezing

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Children vith recurrent wheezing

No interventions assigned to this group

2

Healthy children

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Children with recurrent wheezing ages between 6 months to 6 years old.
• Age and sex matched healthy children for control group.
• Parental/guardian permission (informed consent)

Exclusion Criteria

• Systemic corticosteroid use in the last 30 days
• Chronic lung diseases including cystic fibrosis
• Immunodeficiency
• Known renal or hepatic dysfunction
• Respiratory truck infections in the last 30 days
• Anatomic abnormalities of the respiratory tract
• Suspected foreign body aspiration or croup
• Immunosuppressive or immunostimulant treatment

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kecioren Education and Training Hospital

OTHER

Sponsor Role: lead

Responsible Party

Cem Hasan Razi

Kecioren Education and Training Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

C H RAZI, MD

Role: STUDY_DIRECTOR

Kecioren Education and Training Hospital

C H RAZI, MD

Role: PRINCIPAL_INVESTIGATOR

Kecioren Education and Training Hospital

Locations

Kecioren Eğitim Araştırma Hastanesi

Ankara, Kecioren, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2008-08-11

Identifier Type: -

Identifier Source: org_study_id