Evaluation of Toxic Metals, Trace Elements and Total Antioxidant Activity in Children With Recurrent Wheezing
Sectional Prospective Randomised Study of Evaluation Toxic Metals, Trace Elements Status and Total Antioxidant Activity in Children With Recurrent Wheezing.
1 other identifier
observational
95
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2007
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 8, 2008
CompletedFirst Posted
Study publicly available on registry
September 9, 2008
CompletedMarch 15, 2012
August 1, 2008
10 months
September 8, 2008
March 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hair toxic metal and trace element status in the two groups
6 months
Secondary Outcomes (2)
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
Study Arms (2)
1
Children vith recurrent wheezing
2
Healthy children
Eligibility Criteria
Group 1: Children with recurrent wheezing Group 2: Age and sex matched healthy children
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kecioren Eğitim Araştırma Hastanesi
Ankara, Kecioren, 06380, Turkey (Türkiye)
Biospecimen
Group 1: Children with recurrent wheezing. Plasma and Hair specimen are retined Group 2: Healthy children. Plasma and Hair specimen are retined
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
C H RAZI, MD
Kecioren Education and Training Hospital
- PRINCIPAL INVESTIGATOR
C H RAZI, MD
Kecioren Education and Training Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Kecioren Education and Training Hospital
Study Record Dates
First Submitted
September 8, 2008
First Posted
September 9, 2008
Study Start
September 1, 2007
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
March 15, 2012
Record last verified: 2008-08