NCT00749528

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2008

Completed
Last Updated

March 15, 2012

Status Verified

August 1, 2008

Enrollment Period

10 months

First QC Date

September 8, 2008

Last Update Submit

March 14, 2012

Conditions

Keywords

WheezingHair trace elementsHair toxic metalsOxidative stress

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

Age6 Months - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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)

Location

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

MeSH Terms

Conditions

AsthmaRespiratory Sounds

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • C H RAZI, MD

    Kecioren Education and Training Hospital

    STUDY DIRECTOR
  • C H RAZI, MD

    Kecioren Education and Training Hospital

    PRINCIPAL INVESTIGATOR

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

Locations