- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00749528
Evaluation of Toxic Metals, Trace Elements and Total Antioxidant Activity in Children With Recurrent Wheezing
Sectional Prospective Randomised Study of Evaluation Toxic Metals, Trace Elements Status and Total Antioxidant Activity in Children With Recurrent Wheezing.
Study Overview
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
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Kecioren
-
Ankara, Kecioren, Turkey, 06380
- Kecioren Eğitim Araştırma Hastanesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
1
Children vith recurrent wheezing
|
2
Healthy children
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hair toxic metal and trace element status in the two groups
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To compare plasma total antioxidant activity in the two groups.
Time Frame: 6 months
|
6 months
|
Effect of heavy metals and trace elements on plasma cytokine levels and difference between the two groups
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008-08-11
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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