Genetic Susceptibility to Childhood Respiratory IIlness in Mexico City

Sponsor
National Institute of Environmental Health Sciences (NIEHS) (NIH)
Overall Status
Completed
CT.gov ID
NCT00339521
Collaborator
(none)
2,362
1
258.7
9.1

Study Details

Study Description

Brief Summary

We propose to add a collection of genetic material to a clinical trial of anti-oxidant supplementation for the amelioration of asthma in 7-12 year olds being conducted at a public pediatric hospital in Mexico City. The anti-oxidant study has been approved by the Institutional Review Board of the National Institute of Public Health in Mexico City and is scheduled to begin in September 1998. The purpose of this add-on study is to examine genetic polymorphisms that may be related to asthma. Asthma cases will be compared with their parents as controls. In partaicular, we will save the buffy coat from the blood collection being done on the asthmatic child for measurements of plasma micronutrients in the anti-oxidant trial for extraction of DNA. This part of the sample would otherwise be discarded. In addition, we will enroll the parents of the asthmatic child as controls for the child. From the parents, either a 10 ml blood sample or if they prefer, a sample of buccal cells will be collected. Although our current plan is to compare the asthmatic child to the parents using statistical methods based on the "transmission disequilibrium test" because research into various family designs for candidate gene studies is rapidly evolving and various sibling control sample strategies have been discussed, we would also like to collect a genetic sample on as many of the child's siblings as possible with priority given to those closest in age. This will enhance the future usefulness of the samples. We anticipate enrolling approximately 200 families....

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    We propose to add a collection of genetic material to a clinical trial of anti-oxidant supplementation for the amelioration of asthma in 7-12 year olds being conducted at a public pediatric hospital in Mexico City. The anti-oxidant study has been approved by the Institutional Review Board of the National Institute of Public Health in Mexico City and is scheduled to begin in September 1998. The purpose of this add-on study is to examine genetic polymorphisms that may be related to asthma. Asthma cases will be compared with their parents as controls. In particular, we will save the buffy coat from the blood collection being done on the asthmatic child for measurements of plasma micronutrients in the anti-oxidant trial for extraction of DNA. This part of the sample would otherwise be discarded. In addition, we will enroll the parents of the asthmatic child as controls for the child. From the parents, either a 10 ml blood sample or if they prefer, a sample of buccal cells will be collected. Although our current plan is to compare the asthmatic child to the parents using statistical methods based on the "transmission disequilibrium test" because research into various family designs for candidate gene studies is rapidly evolving and various sibling control sample strategies have been discussed, we would also like to collect a genetic sample on as many of the child's siblings as possible with priority given to those closest in age. This will enhance the future usefulness of the samples. We anticipate enrolling approximately 200 families.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    2362 participants
    Observational Model:
    Family-Based
    Time Perspective:
    Cross-Sectional
    Official Title:
    Genetic Susceptibility to Childhood Respiratory Illness in Mexico City
    Actual Study Start Date :
    May 15, 1999
    Actual Primary Completion Date :
    Feb 12, 2007
    Actual Study Completion Date :
    Dec 3, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Case-Parent Triad

    Childhood Asthmatics (aged 4-17) are Cases; biologic parents of cases are genetic Controls.

    Outcome Measures

    Primary Outcome Measures

    1. To create a resource to examine genetic susceptibility to asthma in Mexico City. [End of Study]

      The role of asthma candidate genes in the association between ozone exposure and asthma incidence.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • INCLUSION CRITERIA:

    Moderate to severe asthma, ages 7-12 and residing within 5 km of a particular ambient air pollution monitoring station.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Infantil de Mexico Federico Gomez Mexico City Mexico

    Sponsors and Collaborators

    • National Institute of Environmental Health Sciences (NIEHS)

    Investigators

    • Principal Investigator: Stephanie London, M.D., National Institute of Environmental Health Sciences (NIEHS)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    National Institute of Environmental Health Sciences (NIEHS)
    ClinicalTrials.gov Identifier:
    NCT00339521
    Other Study ID Numbers:
    • 999999028
    • OH99-E-N028
    First Posted:
    Jun 21, 2006
    Last Update Posted:
    Dec 4, 2020
    Last Verified:
    Dec 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Institute of Environmental Health Sciences (NIEHS)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 4, 2020