Clinical trial NCT00749528: Evaluation of Toxic Metals, Trace Elements and Total Antioxidant Activity in Children With Recurrent Wheezing
Official title: Sectional Prospective Randomised Study of Evaluation Toxic Metals, Trace Elements Status and Total Antioxidant Activity in Children With Recurrent Wheezing.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Wheezing
Keywords: Wheezing
Hair trace elements
Hair toxic metals
Oxidative stress
Lead sponsor: Kecioren Education and Training Hospital
Sponsor class: OTHER
First posted: 2008-09-09
Enrollment: 95
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Group 1: Children with recurrent wheezing Group 2: Age and sex matched healthy children

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

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

Primary outcomes:
measure: Hair toxic metal and trace element status in the two groups
timeFrame: 6 months
Secondary outcomes:
measure: To compare plasma total antioxidant activity in the two groups.
timeFrame: 6 months
measure: Effect of heavy metals and trace elements on plasma cytokine levels and difference between the two groups
timeFrame: 6 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Kecioren Eğitim Araştırma Hastanesi
state: Kecioren
Study officials:
affiliation: Kecioren Education and Training Hospital
name: C H RAZI, MD
role: STUDY_DIRECTOR
affiliation: Kecioren Education and Training Hospital
name: C H RAZI, MD
role: PRINCIPAL_INVESTIGATOR
References: