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

Asthma Clinical Trial

Official title:

Sectional Prospective Randomised Study of Evaluation Toxic Metals, Trace Elements Status and Total Antioxidant Activity in Children With Recurrent Wheezing.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00749528
• Other study ID #: 2008-08-11
• 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

• Asthma
• Wheezing

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