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

Sponsored by:	Kecioren Education and Training Hospital
Information provided by:	Kecioren Education and Training Hospital
ClinicalTrials.gov Identifier:	NCT00749528

Purpose

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.

Condition
Asthma Wheezing

MedlinePlus related topics: Antioxidants Asthma

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Sectional Prospective Randomised Study of Evaluation Toxic Metals, Trace Elements Status and Total Antioxidant Activity in Children With Recurrent Wheezing.

Further study details as provided by Kecioren Education and Training Hospital:

Primary Outcome Measures:

Hair toxic metal and trace element status in the two groups [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare plasma total antioxidant activity in the two groups. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Effect of heavy metals and trace elements on plasma cytokine levels and difference between the two groups [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Group 1: Children with recurrent wheezing. Plasma and Hair specimen are retined Group 2: Healthy children. Plasma and Hair specimen are retined

Enrollment:	95
Study Start Date:	September 2007
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Children vith recurrent wheezing
2 Healthy children

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

Ages Eligible for Study:	6 Months to 6 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Group 1: Children with recurrent wheezing Group 2: Age and sex matched healthy children

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00749528

Locations

Turkey, Kecioren
Kecioren Eğitim Araştırma Hastanesi
Ankara, Kecioren, Turkey, 06380

Sponsors and Collaborators

Kecioren Education and Training Hospital

Investigators

Study Director:	C H RAZI, MD	Kecioren Education and Training Hospital
Study Chair:	G YILMAZ, MD,PhD	Kecioren Education and Training Hospital
Principal Investigator:	C H RAZI, MD	Kecioren Education and Training Hospital

More Information

No publications provided

Responsible Party:	Kecioren Education and Training Hospital ( Kecioren Education and Training Hospital )
Study ID Numbers:	2008-08-11
Study First Received:	September 8, 2008
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00749528 History of Changes
Health Authority:	Turkey: Ethics Committee; Turkey: Ministry of Health

Keywords provided by Kecioren Education and Training Hospital:

Wheezing
Hair trace elements
Hair toxic metals
Oxidative stress

Study placed in the following topic categories:

Signs and Symptoms
Respiratory Sounds
Antioxidants
Signs and Symptoms, Respiratory
Stress

Asthma
Trace Elements
Micronutrients
Recurrence

Additional relevant MeSH terms:

Signs and Symptoms
Respiratory Sounds
Antioxidants
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs

Signs and Symptoms, Respiratory
Trace Elements
Micronutrients
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009