Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cem Hasan Razi, Kecioren Education and Training Hospital
ClinicalTrials.gov Identifier:
NCT00749528
First received: September 8, 2008
Last updated: March 14, 2012
Last verified: August 2008
History of Changes
  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

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

Resource links provided by NLM:

MedlinePlus related topics: Antioxidants Asthma
U.S. FDA Resources

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

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 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
Principal Investigator: C H RAZI, MD Kecioren Education and Training Hospital
  More Information

No publications provided

Responsible Party: Cem Hasan Razi, Kecioren Education and Training Hospital
ClinicalTrials.gov Identifier: NCT00749528     History of Changes
Other Study ID Numbers: 2008-08-11
Study First Received: September 8, 2008
Last Updated: March 14, 2012
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

Additional relevant MeSH terms:
Asthma
Respiratory Sounds
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
 Signs and Symptoms, Respiratory
Signs and Symptoms
Antioxidants
Trace Elements
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Growth Substances

ClinicalTrials.gov processed this record on May 19, 2013