Sectional Prospective Randomised Study of Evaluation Toxic Metals, Trace Elements Status and Total Antioxidant Activity in Children With Recurrent Wheezing.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 95
- Locations
- 1
- Primary Endpoint
- Hair toxic metal and trace element status in the two groups
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 6 Months to 6 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Hair toxic metal and trace element status in the two groups
Time Frame: 6 months
Secondary Outcomes
- To compare plasma total antioxidant activity in the two groups.(6 months)
- Effect of heavy metals and trace elements on plasma cytokine levels and difference between the two groups(6 months)
Investigators
Cem Hasan Razi
Kecioren Education and Training Hospital
Kecioren Education and Training Hospital