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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00749528
Other study ID # 2008-08-11
Secondary ID
Status Completed
Phase N/A
First received September 8, 2008
Last updated March 14, 2012
Start date September 2007
Est. completion date July 2008

Study information

Verified date August 2008
Source Kecioren Education and Training Hospital
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics CommitteeTurkey: Ministry of Health
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 95
Est. completion date July 2008
Est. primary completion date July 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Months to 6 Years
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Kecioren Egitim Arastirma Hastanesi Ankara Kecioren

Sponsors (1)

Lead Sponsor Collaborator
Kecioren Education and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hair toxic metal and trace element status in the two groups 6 months No
Secondary To compare plasma total antioxidant activity in the two groups. 6 months No
Secondary Effect of heavy metals and trace elements on plasma cytokine levels and difference between the two groups 6 months No
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